bluuebunny/crossref_metadata_2025 huggingface dataset:
Caring for adult survivors of childhood cancer: A primary care based adult transition clinic.
Authors: Lowry Becky N. , Alsman Kyla , McClellan Wendy , Klemp Jennifer R. , Krebill Hope , Al-hihi Eyad , Doolittle Gary C. , Fulbright Joy M.
Published: February 2017

40

Background: Long-term survival is an expected outcome for childhood cancer patients. Caring for adults who are childhood cancer survivors requires dedicated late effects monitoring. Recognizing transition challenges from pediatric to adult and oncologic to primary care settings, we developed a dedicated monthly survivorship transition clinic (STC) in an internal medicine office at the University of Kansas Medical Center. We describe the first year practice experience (2014-2015). Methods: Retrospective chart review was completed on 41 STC patients - age 20 to 52 years. Each survivor self-selected to establish in STC, with either consultative survivorship care (correspondence sent to existing primary care physician (PCP)) or combined primary and survivorship care (if no established PCP). Selections were recorded. Two oncology providers performed blinded independent reviews of treatment summaries and scored these using Children’s Hospital of Philadelphia Intensity of Treatment Rating scale (ITR-3). If scores differed, discussion determined consensus. Scores were provided to the STC and unblinded. ITR-3 scores were matched with data on subspecialty referral patterns for each survivor to determine if ITR-3 scores correlated with referral needs. Results: Of 41 patients, 26 (63%) requested PCP and survivorship care. Only 15 (37%) had an established PCP. Survivors were grouped by ITR-3 into low (1 or 2) or high (3 or 4) intensity scores. Subspecialty referrals in each group were analyzed as follows: total number of referrals / average referrals per survivor / median referral number. Referral data: low intensity group 14 / 1.27 / 1, high intensity group 96 / 3.56 / 3. Conclusions: Despite complex medical histories and long term follow-up needs, a high percentage of Midwest cancer survivors were in need of survivorship, PCP and subspecialty care emphasizing the importance of intentional transition efforts. ITR-3 scores correlated with subspecialty referral needs. Future research will include an increased number of survivors to determine further predicative value of this scale in estimating survivor needs complexity.
A clinical placement program for primary care professionals at a comprehensive cancer centre.
Authors: Jefford Michael , Evans Judy , Nolte Linda , Piper Amanda , Simkiss Liz , Whitfield Kathryn
Published: February 2017

44

Background: Primary care physicians (PCPs) and primary care nurses (PCNs) are likely to have a critical role in providing care for cancer survivors, especially following the end of cancer treatments. Generalists (PCPs and PCNs) express a need for information and training in post-treatment care. Based on models in other contexts a clinical placement program was developed at a comprehensive cancer centre to determine (1) its feasibility and acceptability, and (2) whether learning needs were met. Methods: Five clinical services (breast, lower gastro-intestinal, urology, skin and melanoma, late effects) participated. The program was advertised to generalists, intending to recruit 5 PCPs and 10 PCNs. Generalists received professional development points and partial reimbursement for lost income through a stipend. Pre-placement educational materials were provided. Participants were interviewed one-on-one pre and post-placement. The relevant human research ethics committee approved all aspects of the project. Results: The program exceeded recruitment goals: 16 PCPs, 12 PCNs and 9 oncologists participated. Generalists rated the placement highly: program learning outcomes entirely (63%) or partially (37%) met; personal learning needs entirely (70%) or partially met (30%); relevance to practice entirely (89%), partially (11%). Consistent themes from interviews: generalists would recommend the program to colleagues and could identify knowledge and skills transfer, however learning was largely by observation, rather than participation. Learning opportunities were skewed toward generalists, rather than oncologists. All participants showed enthusiasm to address the challenges of providing shared care for survivors. Conclusions: A clinical placement program for generalists is feasible and highly regarded. Participants described challenges to providing quality post-treatment shared care, but a willingness to address these. Future programs should consider the learning needs of cancer centre professionals.
Developing electronic health record (EHR)-based program to deliver survivorship care plans (SCPs) and visits at the UW Breast Center.
Authors: Seaborne Lori A. , Hueneberg Karol , Bohler Aaron , Schroeder Gillian , White Terri , Sesto Mary E , Haine James Edward , Wilke Lee G. , Neuman Heather B. , Tevaarwerk Amye
Published: February 2017

56

Background: Accreditation guidelines require all breast cancer patients receive SCPs within 6 months of end of treatment (EOT) in 2016. SCPs require significant resources to provide, which EHR assistance might decrease. Our objective was to develop a standardized program for creating, providing, and tracking SCPs using an EHR. Methods: Clinicians and EHR analysts developed processes for implementing an EHR-based program, using our existing SCP to guide overall structure. We piloted this program 5/2015-6/2015 to identify barriers & facilitators to creating EHR-based SCPs, providing EHR-based visits and EHR-based tracking of both. Results: The pilot included 24 patients (2% of annual volume). Facilitators were: 1) pre-entry of cancer history, 2) clearly defined responsibilities for SCP & visit; barriers were: 3) no identified method to assess concerns or track referrals, 4) variability in EOT due to treatment heterogeneity, 5) limited time during routine follow up for SCP provision. The following changes were implemented: 1) SCP auto-population, requiring consensus on essential clinical data, 2) assigning staff roles (MD, NP/PA, RN) for all aspects of SCP creation & visit provision; 3) creating 1-page survey addressing NCCN recommended topics to pre-screen for concerns discussed at SCP visit and using a visit template to track topics covered plus information and referrals provided, 4) establishing processes and delivery dates for SCP & visit to newly diagnosed patients and 5) developing algorithms for referral for SCP & visit (4-8 weeks from EOT) including adding “SCP visits” to EHR-chemotherapy plans and other auto-reminders. Clinic-wide implementation began 7/2015; updated results will include: EHR-tracked, provision rate, type and frequency of survivor concerns and referral patterns and time for SCP creation and visits. Survivor/clinician satisfaction with EHR-based program will also be included. Conclusions: EHR-based SCP creation, provision and tracking is feasible. Future plans include assessing time and personnel resources required, and comparing the accuracy of EHR-tracking with cancer registry data or other standards used to address guideline compliance.
Challenges in the implementation of survivorship care plans in an NCI-designated cancer center.
Authors: Mendelsohn Mary , Mortimer Joanne E. , Popplewell Leslie , Lai Lily L. , Maghami Ellie , Economou Denice
Published: February 2017

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Background: The development and initiation of Survivorship Care Plans (SCPs) across all disease sites was identified as a Strategic Initiative Goals for 2015 by the Clinical Cancer Committee. The 2012 Commission on Cancer requirements for certification provided an additional incentive to meet this goal. Establishing a process that includes the development and distribution of a SCP’s within the electronic medical record (EMR) is necessary to improve on the completion of SCP’s and to improve the utilization of surveillance tests in cancer survivors. We describe the process developed at a free-standing NCI cancer center to meet the standard of SCP provision to all cancer patients. Methods: A multi-disciplinary subcommittee of the Cancer Committee was designated to develop the overall strategic plan for the implementation of this standard. It met with disease teams to facilitate a treatment summary from Cancer Registry data, identify patient reported symptoms using a self report tablet (SupportScreen). Electronic care plans were created using survivorship research program templates and ASCO framework for each disease site team. The disease team Nurse Care Coordinator inputs information into the eSCP. Results: Templates have been established within the EMR in the documents section under survivorship care plan title. These can be initiated and modified when the Nurse Care Coordinator chooses to start them. The disease teams have established their time points for SCP presentation to their patients. Using the cancer registry to provide data related to staging, treatments and genetic testing has helped minimize development time. Individual survivor’s concerns will be reflected in patient reports and physician symptom documentation. This eSCP completion process is a pilot program within the breast cancer disease team and will be expanded to include patients with head & neck and hematologic malignancies with a goal of including all patients by mid 2016. Conclusions: The goal of improving survivorship care coordination and compliance with surveillance guidelines is challenging. Maximizing available interdisciplinary resources has helped to create a viable Survivorship Care plan at our institution.
Continuum of care: Establishment of a comprehensive cardio-oncology program.
Authors: Aseyev Olexiy , Gosh Nina , Sulpher Jeffrey Allen , Johnson Christopher , Stadnick Ellamae , Turek Michele , Dent Susan Faye
Published: February 2017

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Background: Cardiac disease in individuals with cancer is common, impacts survival, the ability to tolerate cancer treatments and quality of life. Cardio-oncology is a novel interdisciplinary approach to the management of cancer patients with treatment-induced cardiotoxicity. The goal of our program is two-fold: a) establishment of a hospital based cardio-oncology clinic to rapidly assess and manage cancer patients with cardiotoxicity related to their cancer treatment and b) provide continuum of care for these patients with the establishment of a cardiovascular survivorship program. Methods: In 2008, in collaboration with oncologists, cardiologists, pharmacy and nursing we established a multidisciplinary cardio-oncology clinic at The Ottawa Hospital. Referrals are primarily form treating oncologists. The clinics take place 3-4 half days per month and are conducted by 3 dedicated cardiologists. Patient data including demographics, cancer type and treatment, cardiovascular risk factors, treatment and clinical outcomes of each patient are being collected. Results: We have seen over 800 patients with solid and hematological malignancies. Clinical outcomes of patients referred from 10/2008 to 01/2013 have previously been reported (Sulpher J. et al 2014). The majority of patients referred were able to successfully complete their cancer therapy (79.7%), reflective of the large breast cancer population seen in this clinic. A third of patients achieved stable left ventricular ejection fractions with cardiac intervention and 41% received cardiac medications. Overall survival and long term cardiac outcomes will be reported. Conclusions: While these initial results are encouraging the impact of cardiotoxicity experienced by cancer patients and long term cardiac outcomes are unknown. In an effort to improve the cardiovascular care of cancer survivors we are currently developing a Cardiovascular Survivorship Program; patients will be referred from our hospital based cardio-oncology clinic to a specialized community clinic, for long-term surveillance and optimization of cardiovascular health. This initiative represents a continuum of care from hospital to community and is the first such program in Canada.
Implementation of survivorship care plans: Lessons learned at the Kaiser Permanente Oakland Medical Center.
Authors: Washington Pamela Kim , Li Yan , Durzinsky Dennis S , Duffy James , Shim Veronica , Barnett Nicole M , Warren Nakeia , Stodd Kay
Published: February 2017

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Background: Beginning in 2015, the Commission on Cancer (CoC) requires accredited facilities to provide eligible patients with a Survivorship Care Plan (SCP). While the benefits of SCPs in the quality and continuity of care are well documented in the literature, there is a dearth of information regarding best practices for implementation. Here we describe lessons learned in the development of a SCP at the Kaiser Permanente Oakland Medical Center (OMC). Methods: Adult patients with a diagnosis of stage 1-3 cancer who received curative treatment were identified by the Northern California Kaiser Permanente Cancer Registrar. Consistent with CoC guidelines for 2015, 10% of all eligible patients (n = 1160) are required to receive a SCP 3-6 months following active treatment. Thus, a total of 116 patients with a diagnosis of breast, colon, lung/bronchus, prostate, or melanoma of the skin at OMC were given a SCP. The implementation timeframe was July to December 2015. Use of a modified ASCO template was recommended for its rigor across the required domains. Following template approval by the Comprehensive Cancer Committee (CCC), a workflow consisting of identifying patients’ last treatment and manual data entry by a Physician Assistant (PA) as well as automated data population in the Kaiser Permanente electronic medical record system was developed. Completed SCPs were then provided to patients during a clinic visit. The workflow process was refined as appropriate based on feedback from staff & physicians. Results: Depending on the scope of treatment, mean preparation time is 10 minutes per plan using specific diagnosis codes via an electronic medical record system. Further, it takes 30 minutes for a PA or other Ancillary personnel to discuss the plan with a patient. Patient response was generally positive upon receipt of the plan. Conclusions: Successful SCP implementation is contingent upon engagement from multiple stakeholders. Per standard CoC 3.3, the implementation rate will increase annually from 10% in 2015 to 100% by 2019. Careful consideration to workflow processes and resources planning be must factored into achieving 100% compliance across all disease sites by 2019.
Measuring and understanding quality of survival in oncology.
Authors: Hudgens Stacie , Forsythe Anna , Lloyd Andrew , Lapuerta Pablo
Published: February 2017

e291

Background: Health status, burden of illness, and quality of life (QOL) are considered crucial for clinical decision making in cancer. More specifically, quality of survival (QOS) in patients with cancer must be paramount in treatment considerations from early stage disease to palliative care. Measuring QOL provides information beyond biomedical outcomes, offers a unique understanding from the patient's perspective, and has demonstrated influence over study conclusions where differences in QOL are more often detected in studies comparing intervention to no intervention rather than comparative studies with systemic therapies. Methods: This panel presentation is focused on the crossfunctional perspectives of critical research areas for understanding QOS in oncology. As such, this presentation seeks to address the need for patient-focused research in oncology including: 1) the importance of the patient's voice in early and metastatic disease, 2) what endpoints should we consider in oncology trials for understanding the impact on patients, 3) modeling time to patient reported decline as a critical endpoint in understanding survival, 4) quality of life as a story rather than a statistic, 5) understanding health states for response and progression. Results: The authors of this panel seek to present real world examples for each of the above topics as well as introduce methodologies for improving QOS value messaging in oncology. Conclusions: In cancer studies, the primary response is measured as survival benefit with the ability to measure biomarkers such as tumor response, blood levels, etc. However, measureable endpoints in oncology from patient report contribute to the understanding of symptom improvement or decline (change over the course of treatment), change in function (e.g., physical functioning), side effects (treatment toxicity; e.g., patient reported potential with the PRO common terminology criteria for adverse events), economic aspects, interaction between biomarkers of progression or response and patient-reported symptoms, function, and QOL should be carefully estimated to fully understand treatment efficacy and safety, and inform patients of duration and cycle of toxicity onset; disease symptoms and changes.
Chemoprevention and epigenetic multitargeted approach.
Authors: Nezami M. A.
Published: February 2017

e297

Background: In 2012 there were 11,957,599 advanced cancer cases in the US reported by CDC and the incidence has been almost unchanged over the previous 8 years (482,000 cases in 2000 versus 456,000 cases in 2008). There has been an annual percentage change of only (-0.6) between years 1999 to 2008 in cancer incidence. It is described in recent literature that epigenetic alterations are at least if not more important than genetic defects for the development and progression of malignant diseases. Transcriptional therapy is a very promising form of cancer treatment that is being extensively evaluated. It is speculated that inhibitors of DNA methylation and histone deacetylases can reactivate expression of tumor suppressor genes. Hypermethylation and transcription silencing of suppressor genes has been shown in 33% of breast cancers, 60% of prostate CA and 92% of colon CA. The value of combination therapy both in chemoprevention, as well as treatment in patients with cancer is extremely important and can cause a significant shift in the current practice of oncology and cancer prevention, the results in clinical studies have been poor as the target histone hyperacetylation does not correlate with survival (possibly due to P 16/21 resistance and unselectiveness of the conventional therapies/targets). Methods: In vitro application of epigenetic modifiers, consisting of nontoxic natural substances tested in cell cultures showed preliminary results confirming apoptosis. Application of the relevant scientific merits described above, using combination of epigenetic modifiers, and natural compounds in a protocol called Multi targeted epigenetic therapy (MTET) in a set of advanced patients showed synergistic effect which was clinically relevant. Results: Clinical application of this method of treating cancer has caused promising preliminary results. We present the summary of outcomes in one hundred cases of advanced cancer (refractory solid tumors) with thirteen cases, described in detail. Conclusions: Our preliminary findings were encouraging and supports further research in a large randomized trial to evaluate the efficacy of such method, in refractory and advanced solid tumors.
Transrectal MR-guided laser focal therapy of recurrent prostate cancer in a patient post-proton therapy: A case study.
Authors: Greenwood Bernadette Marie , May Stuart , Feller John Francis
Published: February 2017

e298

Background: Prostate cancer is commonly managed with radical prostatectomy (RP) or radiation therapy (RT). 20-40% of men undergoing RP experience biochemical recurrence (BCR) before 10 years. 30-50% or those receiving RT experience BCR. Treatment options for these men are limited and include: salvage radiation, close surveillance, androgen deprivation therapy (ADT), or participation in a clinical trial. Our IRB-approved study evaluated the use of transrectally delivered, MR-guided laser focal therapy with real-time MR thermometry for the treatment of recurrent prostate cancer. Methods: 63 y.o. patient treated September, 2014 with MR-guided laser focal salvage therapy for locally recurrent prostate cancer, Gleason score 4+5 involving the transition zone far anteriorly at the base level measuring 1.4 x 1.1 x 1.3 cm. The patient was originally diagnosed with Gleason score 4+3 adenocarcinoma of the prostate by MR ultrasound fusion biopsy in 2012 and subsequently underwent treatment with proton beam radiation therapy. Results: MR-guided biopsy of the prostate August, 2014 confirmed the presence of locally recurrent PCa. Before MR-guided laser focal therapy, the biochemical recurrence was documented with an elevated serum PSA equal to 5.7. The 3- and 6-month post laser focal therapy serum PSA levels were 0.5. It reached a nadir of 0.3 at one year following the laser ablation. Patient had negative 6-month follow-up MR-guided biopsy of treatment region and remains on active surveillance Conclusions: Following proton beam radiation therapy, transrectal MR-guided laser focal therapy achieved oncologic control at 12 months post-treatment. Clinical trial information: 02243033.
Staging of gastric cancer: Comparison of post-operative pathologic staging to pre-operative CT and endoscopic ultrasonographic staging.
Authors: Jung Sung Min , Cheung Dae Young , Kim Jin Il , Kim Jae J. , Lee Sang Woo , Jung Hyun Chae
Published: February 2017

11

Background: Stomach CT and endoscopic ultrasonography are used for evaluating pre-operative staging of gastric cancer. The aim of this study was to compare the pre-operative CT and endoscopic ultrasonographic staging to post-operative pathologic staging. Methods: We reviewed medical records of 567 patients with gastric cancer from 2012 to 2015, and compared their pre-operative CT staging to post-operative pathologic staging. Among the 567 patients, 149 patients underwent pre-operative endoscopic ultrasonographic staging, so we compared their pre-operative endoscopic ultrasonographic staging to post-operative pathologic staging. We also investigated lymph node metastasis in 146 patients with gastric cancer invading submucosa, planning to undergo endoscopic submucosal dissection. Results: The numbers of patients diagnosed as T1, T2, T3, T41, and T4b by pre-operative CT staging were 327, 97, 93, 46, and 4, respectively. However, the numbers of patients diagnosed as T1, T2, T3, T41, and T4b by post-operative pathologic staging were 208, 153, 53, 83, 62, and 8, resulting the pre-operative CT staging to be under-estimated. Similarly, pre-operative endoscopic ultrasonographic staging was also under-estimated, as although 48, 67, 32, and 2 patients were diagnosed as T1a, T1b, T2, and T3, respectively, by the pre-operative endoscopic ultrasonographic staging, post-operative pathologic staging revealed 72, 55, 13, 7, and 2 patients. In patients with gastric cancer invading submucosa (sm), there were 56 patients with sm1 invasion, 32 patients with sm2 invasion, and 91 patients with sm3 invasion. Lymph node metastasis was observed in 7 patients with sm1 invasion, 3 patients with sm2 invasion, and 22 patients with sm3 invasion. Poorly cohesive gastric cancer was the most common pathologic diagnosis in patients with metastatic lymph node. Conclusions: Physicians should keep in mind that pre-operative stomach CT and endoscopic ultrasonographic staging can be under-estimated compared to post-operative pathologic staging. Also, patients with poorly cohesive adenocarcinoma had more lymph node metastasis than patients with differentiated adenocarcinoma.
Endoscopic stenting for esophageal leak after minimally invasive esophagectomy.
Authors: Ernst Brenda , Ross Helen J. , Paripati Harshita , Pannala Rahul , Rule William G. , Ashman Jonathan Ben , Harold Kristi L. , Jaroszewski Dawn E.
Published: February 2017

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Background: Anastomotic leaks can occur after esophagectomy and optimal management after minimally invasive esophagectomy (MIE) is not well defined. We reviewed endoscopic management of leaks after MIE in patients undergoing trimodality therapy at Mayo Clinic Arizona. Methods: Records of patients undergoing MIE from November, 2006 to February, 2015 were reviewed after appropriate IRB approval. Results: 148 patients underwent MIE including 136 (91.8%) thoracic and 12 (8.1%) cervical anastomoses. Clinically significant anastomotic leaks were observed in 13 (8.8%) patients with 2 (16%) cervical and 11 (8%) thoracic anastomosis at a median of 6.1 days (0-14). 11 (11%) patients treated with neoadjuvant chemoradiotherapy experienced esophageal leak and 2 who did not receive chemoradiotherapy (4%). For treatment of anastomotic leaks, 10 patients underwent VATS with pleural space irrigation and chest tube replacement, and 11 patients underwent stent deployment at the anastomosis for repair. Stents were placed such that the fistula/leak was in the fully covered portion with the greater portion of the stent residing in the esophageal remnant. Stents were removed at a mean of 54 days (28-114). In 2 patients, overgrowth into the stent body required stent-in-stent placement (fully covered) with removal of both stents. Stents were successful at sealing all leaks. Conclusions: Leaks after MIE represent a small, but significant, morbidity in MIE. The majority can be managed by endoscopic stent placement. Stenting is an effective management tool for postoperative leaks in locally advanced esophageal malignancies.
Role of palliative resection in patients with incurable advanced gastric cancer unfit for chemotherapy.
Authors: Takagi Wataru , Tanizawa Yutaka , Omori Hayato , Nishiwaki Noriyuki , Fujiya Keiichi , Hirata Fumiko , Tatsubayashi Taichi , Honda Shinsaku , Hikage Makoto , Makuuchi Rie , Tokunaga Masanori , Bando Etsuro , Kawamura Taiichi , Terashima Masanori
Published: February 2017

114

Background: Recently, REGATTA trial showed that debulking surgeries followed by chemotherapy did not improve survival outcomes compared to chemotherapy alone for incurable advanced gastric cancer (AGC). Therefore, the standard treatment for incurable AGC without emergent symptom is not gastrectomy plus chemotherapy but chemotherapy alone. However, in patients who are unfit for chemotherapy due to poor performance status (PS), age, or comorbid chronic diseases, the role of palliative gastrectomy remains controversial. The aim of this study is to determine the role of palliative resection in patients with incurable AGC unfit for chemotherapy. Methods: Two hundred and twelve gastric cancer patients having any cause of incurable factors and underwent palliative gastrectomy or bypass operation between November 2002 and December 2014 were enrolled. Of these 212 patients, 64 patients who did not receive any chemotherapy were divided into two groups; Gastrectomy group with 45 patients who underwent palliative gastrectomy (distal gastrectomy in 18, total gastrectomy in 27) and Bypass group with 19 patients who underwent gastrojejunostomy. Survival outcomes and clinicopathologic features were compared between the two groups. Results: The reasons why unfit for chemotherapy were age (15), patients’ refusal (14), poor PS (11), postoperative complications (11), comorbidity (10), disease progression (3). There was no significant difference of clinicopathologic features between the two groups such as, age (MAN; 74.1 vs 77.1, p = 0.198), gender (male/female: 37/8 vs 13/6, p = 0.321), and number of incurable factors 2 or more (51.1% vs 63.2%, p = 0.422) except for postoperative complications of C-D grade 3 or more (24.4% vs 0%, p = 0.025). Median survival time of Gastrectomy group and Bypass group were 154 days (95%CI: 124-253) and 86 days (95%CI: 71-166), respectively, and significantly longer in Gastrectomy group (p = 0.002). Conclusions: These results suggest that palliative gastrectomy may improve survival in patients with incurable advanced gastric cancer unfit for chemotherapy.
Follow-up data from a phase II study of adjuvant S-1/cisplatin chemotherapy followed by S-1 based chemoradiotherapy for advanced gastric cancer.
Authors: Shim Hyun-Jeong , Bae Woo Kyun , Hwang Jun-Eul , Park Young-Kyu , Ryu Seong-Yeop , Nam Taek-Keun , Chung Ik-Joo , Cho Sang-Hee ,   Oncology
Published: February 2017

116

Background: Surgery is the only possible curative treatment for gastric cancer. However, the high recurrence rate makes gastric cancer difficult to cure by surgery alone. The present study was conducted to evaluate the clinical outcomes and toxicity of adjuvant treatment, including S-1/cisplatin chemotherapy followed by radiotherapy with concurrent S-1. Methods: Patients with radically D2-resected adenocarcinoma of the stomach of stage IB–IV (M0) were eligible. Patients were treated with S-1 (40–60 mg depending on the patient’s body surface area) twice daily for 3 weeks and cisplatin (60 mg/m²) intravenously on day 1 every 5 weeks. Patients received CRT (45 Gy of radiation at 1.8 Gy/day, 5 days per week, for 5 weeks with the same dose of S-1 during radiation) followed by two additional cycles of S-1/cisplatin. The primary endpoint was the 3-year disease-free survival (DFS) rate; the secondary endpoints were the 3-year overall survival rate and toxicities. Results: Until May 2012, 46 patients were enrolled, and 34 (73.9%) completed the planned treatment. The median age was 53 years (range: 31–69 years), and the numbers of patients with stage IB, II, III and IV disease were 0, 17, 25 and 4, respectively. Grade 3–4 toxicities were as follows: neutropenia (28.2%), nausea (17.4%), vomiting (8.7%) and anorexia (15.2%). At the time of analysis, after a median follow-up period of 56.5 months (3.03–74.0 months), 16 recurrence events and 15 deaths were reported. The estimated 3-year DFS and survival rates were 65.2% and 76.1%, respectively. The most common site of recurrence was the peritoneum (n = 12). Conclusions: The results of this phase II study show that intensified adjuvant treatment with S-1/cisplatin chemotherapy and S-1-based chemoradiotherapy was effective in reducing disease recurrence. A randomized trial is needed to evaluate the role of the addition of radiation to chemotherapy in adjuvant treatment for gastric cancer. Clinical trial information: NCT01824004.
Long term results and patterns of recurrence from SCOPE 1: A phase II/III randomised trial of definitive chemoradiotherapy (dCRT) plus or minus cetuximab (dCRT+C) in esophageal cancer.
Authors: Mukherjee Somnath , Hurt Chris , Falk Stephen , Gollins Simon , Staffurth John , Ray Ruby , Bridgewater John A. , Cunningham David , Blazeby Jane M. , Roy Rajarshi , Maughan Tim , Griffiths Gareth , Crosby Tom David Lewis
Published: February 2017

118

Background: One of the largest trials in dCRT for localised oesophageal cancer, SCOPE 1 tested the role of adding cetuximab to conventional dCRT, and showed that this was associated with greater toxicity and worse survival. Here we present the long-term outcomes. Methods: Phase II/III trial. Randomisation: cisplatin 60mg/m2 D1 and capecitabine 625mg/m2 daily D1-21 for 4 cycles with/without Cetuximab 400mg/m2 D1 followed by 250mg/m2weekly. RT: 50Gy in 25 fractions given concurrent with cycles 3 and 4. Recruitment: Feb 2008 - Feb 2012, when the IDMC recommended trial closure on the basis of futility. Results: 258 patients (dCRT = 129; dCRT+C = 129) were recruited from 36 centres. Median follow-up (IQR): 46.7 (36.0-49.0) months for all surviving pts. 65.1% (dCRT arm) and 69.8% (dCRT+C arm) of patients had died. Esophageal cancer was the cause in 82.1% and 86.7% of deaths respectively (p = 0.41). Median OS months (95% CI) was 34.5 (24.7-42.3) in dCRT and 24.7 (18.6-31.3) in dCRT+C (HR 1.25, p = 0.137); corresponding 3-year OS (95% CI) was 47.2% (38.2%-55.7%) and 37.6% (29.1%-46.0%). Median PFS (95% CI): 24.1 (15.3-29.9) and 15.9 (10.7-20.8) months respectively (HR1.28, p = 0.114). There was some evidence that local PFS (within RT field) was lower in the dCRT+C arm (HR1.38, p = 0.051). On multivariable analysis including treatment arm, Stage I-II ds (vs Stage III), full-dose RT and higher cisplatin dose intensity ( ≥ 75% vs < 75%) were associated with improved OS and PFS. Patterns of recurrence (n [%]) were similar in both arms (see table). In dCRT arm, 31/38 pts (81.6%) with local relapse within the RT field compared to 40/48 (83.3%) in the dCRT+C arm (p = 0.8). Conclusions: The mature analysis shows unprecedented survival in dCRT arm, comparable to surgical trials (e.g. 3-year OS % [95% CIs] in OE05: CF 39 [35, 44] and ECX 42 [37, 46], in OE02: 31 [27, 36]). OS inferiority of dCRT+C is no longer statistically significant. The lower PFS (within RT field) in the dCRT+C arm was consistent with the lower number of patients receiving full dose of RT in the dCRT+C arm. Clinical trial information: 47718479. [Table: see text]
Outcomes of esophagectomy in elderly patients with esophageal cancer: A population-based study.
Authors: Mikhail Sameh , Hinton Alice , Wuthrick Evan John , Perry Kyle , Merritt Robert , Williams Terence M , Conwell Darwin , Bekaii-Saab Tanios S. , Krishna Somashekar
Published: February 2017

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Background: Studies evaluating the outcome of esophectomy (Esx) in elderly patients (pts) with esophageal cancer (EC) have showed conflicting results. Surgical techniques in Esx have advanced significantly in the last decade. Our study evaluates national trends and outcomes of Esx in elderly pts. Methods: Our analysis includes adult pts aged < 70, 70-79 and > 79 in the Nationwide Inpatient Sample who underwent Esx 2002-2012. We examined temporal trends and performed multivariate analysis for key outcomes controlling for demographics, hospital factors and comorbidities. Results: Inpatient mortality was higher in pts aged > 79 (17%; OR 3.24, 95 CI 2.05, 5.12 N = 1,464) and pts 70-79 (9%; OR 1.44, 95% CI 1.01, 2.06; N = 7,393) compared to pts < 70 (5.26%; N = 20,730). Complication rates and length of stay were 76%, 73% and 64%, and 19.2, 18.4 and 17.1 days in the three age groups, respectively. Inpatient mortality improved significantly for all age groups over the study period (Table). Following Esx, 47%, 64% and 82% of pts aged > 79, 70-79 and < 70, were discharged home, respectively. Across all age groups, most pts (74.7%, 75.6 % and 79.4%, respectively) underwent Esx in urban teaching hospitals. On multivariate analysis for pts aged ≥ 70, rural nonteaching hospitals were associated with higher mortality compared to urban teaching hospitals (OR: 3.18, CI 1.47, 6.86). Complication rates were not significantly different between the two hospital settings. Mortality was higher with congestive heart failure (OR 1.86, 95% CI 1.08, 3.23), chronic lung disease (OR 1.91, CI 1.32, 2.76) and peripheral vascular disease (OR 2.41, CI 1.18, 4.92). Conclusions: Inpatient mortality following Esx has significantly improved over the last decade but remains high in elderly pts especially in nonteaching hospitals. Our data should aid multidisciplinary teams in counseling elderly pts about mortality risk of surgery. Further research is needed to better select elderly patients who will benefit from surgical resection. [Table: see text]
Response to neoadjuvant chemotherapy and impact on survival for resected gastric cancer.
Authors: Greenleaf Erin , Hollenbeak Christopher S , Wong Joyce
Published: February 2017

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Background: This study assesses the survival impact of perioperative chemotherapy, with further analysis of pathologic response to neoadjuvant chemotherapy (NAC), in patients undergoing gastrectomy for gastric cancer (GC) in a large US sample. Methods: Using the 2003-2012 ACS National Cancer Database, 16,128 patients underwent gastrectomy for cancer. Treatment groups were categorized as: NAC, adjuvant chemotherapy, and surgery only. Patients receiving NAC were further categorized as: down-staged, no response, and disease progression. Univariate and multivariate analyses were performed to estimate the impact of treatment on overall survival. Results: Of patients undergoing gastrectomy, 36.6% received NAC, 19.5% received adjuvant chemotherapy, and 43.9% underwent surgery only. Median time of survival was longer in patients with more advanced disease who underwent either NAC or adjuvant chemotherapy versus surgery alone (see Table). In multivariate analysis, patients who received NAC had 20% lower hazard of death than surgery only patients (HR = 0.80, p < 0.0001). Within the NAC cohort (N = 5,909), 47.7% were down-staged, 36.5% had no response, and 15.7% demonstrated disease progression. Having a pathologic response to NAC was associated with having private insurance (OR = 1.22, p < 0.0001), higher socioeconomic status (OR = 1.21, p = 0.003), treatment in the central US (p < 0.0001, both), and undergoing proximal gastrectomy (OR = 1.59, p < 0.0001). Among patients who received NAC, median time of survival was longer if NAC down-staged patients to stages 0 or 1, with no survival difference in advanced stage disease. Conclusions: Neoadjuvant chemotherapy elicits a survival benefit in patients with advanced GC. Pathologic response is achieved in nearly half of patients undergoing NAC and is associated with improved survival, although only when down-staging to early stage disease. [Table: see text] [Table: see text]
Timing of adjuvant chemotherapy and impact on survival for resected gastric cancer.
Authors: Greenleaf Erin , Hollenbeak Christopher S , Wong Joyce
Published: February 2017

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Background: Standard of care for patients with advanced gastric cancer includes administration of adjuvant chemotherapy (ADJ); however, post-operative convalescence often prolongs the interval between surgery and chemotherapy. This study assesses the survival impact of timing of adjuvant chemotherapy in patients undergoing resection for gastric cancer. Methods: The 2003-2012 ACS NCDB was analyzed for patients treated with gastrectomy for cancer. Treatment groups were stratified by time to initiation of ADJ. The categories included: initiation of chemotherapy within 3 months post-operatively, after 3 months post-operatively, and surgery only. Univariate and multivariate analyses were performed. Results: Of 10,242 patients undergoing gastrectomy, 31% received ADJ and 69% underwent surgery only. Median time to receipt of chemotherapy was 52 days. The majority, 87%, received ADJ within 3 months. 13% received ADJ after 3 months. Patients who received ADJ earlier were more frequently younger, female, privately insured, with fewer comorbidities, treated in comprehensive community facilities, and more often with stages II and III disease. In multivariate analysis, patients who received ADJ had a 36% less hazard of death, both with administration within 3 months post-operatively and later, compared to surgery only patients (HR = 0.64, p < 0.0001, both). Among patients who received ADJ within 3 months and after, median time of survival was not different at a statistically significant level, when stratified by pathologic stage (see Table). Median time of survival was longer for both chemotherapy cohorts when compared with surgery only, specifically in patients with pathologic stage II, III, and III disease. Conclusions: Time to initiation of adjuvant therapy following surgery does not impact survival. With improved survival over surgery only, even delayed initiation of chemotherapy should be offered, when appropriate. [Table: see text]
Transthoracic anastomotic leak after esophagectomy: Still a catastrophe?
Authors: McCarter Martin , Ryan Carrie , Meguid Robert , Paniccia Alessandro
Published: February 2017

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Background: Leaks from intrathoracic esophagogastric anastomosis are thought to be associated with higher rates of morbidity and mortality than leaks from cervical anastomosis. We challenge this assumption, and hypothesize that there is no significant difference in mortality based on the position of the esophagogastric anastomosis. Methods: A systematic literature search was conducted using PubMed and Embase databases on all studies published between January 2000 and June 2015 comparing transthoracic (TTE) and transhiatal (THE) esophagectomies. Studies that used alternate reconstruction approaches were excluded. Outcomes analyzed were leak rate, leak-associated mortality, overall 30-day mortality, and overall morbidity. Meta-analyses were performed using Mantel Haenszel statistical analyses on studies that reported on leak rates of both approaches. Nominal data are presented as frequency and interquartile range (IQR); measures of the association between treatments and outcomes are presented as odds ratio (OR) with 95% confidence interval (CI). Results: Twenty-one studies (including 3 randomized controlled trials) were included comprising of 7167 patients (54% TTE). THE approach yields a higher anastomotic leak rate (12%; IQR: 11.6% - 22.1%) than TTE (9.8%; IQR: 6.0% - 12.2%) (OR: 1.83 [0.34-06.92]), without any difference in leak-associated mortality (7.1% TTE vs. 4.6% THE; OR: 1.83, [0.39-8.52]). There was no difference in overall 30-day mortality (3.9% TTE vs. 4.3% THE; OR: 0.86, [0.66-1.13]) and morbidity (59.0% TTE vs. 66.6% THE; OR: 0.76, [0.37-1.59]). Conclusions: Transthoracic esophagectomy is associated with a lower leak rate and does not result in higher morbidity or mortality than transhiatal esophagectomy. The previously assumed higher rate of transthoracic leak-associated mortality is overstated, thus allowing surgeon discretion and other factors to influence the choice of intrathoracic versus cervical esophagogastric anastomosis.
A multinational phase II clinical trial of neoadjuvant imatinib for large gastrointestinal stromal tumor of the stomach.
Authors: Yang Han-Kwang , Kurokawa Yukinori , Ryu Min-Hee , Cho Haruhiko , Park Sook Ryun , Masuzawa Toru , Lee Hyuk-Joon , Matsumoto Sohei , Kwon Oh Kyoung , Honda Hiroshi , Lee Kyung Hee , Yamamoto Kazuyoshi , Kong Seong-Ho , Ishikawa Takashi , Yook Jeong Hwan , Nabeshima Kazuhito , Hahn Seokyung , Shimokawa Toshio , Kang Yoon-Koo , Nishida Toshirou
Published: February 2017

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Background: Neoadjuvant therapy is expected to reduce the risk of primary surgery, such as rupture of the tumor, hemorrhage, and multi-visceral resection, and to improve survivals for patients with a large gastric gastrointestinal stromal tumor (GIST). This study aims to evaluate the efficacy and safety of neoadjuvant imatinib therapy for a large gastric GIST. Methods: Patients with gastric GIST, which is 10cm or larger and without metastasis, received neoadjuvant imatinib (400mg/day) for 6 months, and up to 9 months if maximal response is expected. Postoperative adjuvant imatinib was prescribed for at least 1 year and up to 3 years according to adjuvant treatment guideline. The primary endpoint was complete (R0) resection rate. A primary analysis were performed by the time all the operations were finished, to examine the efficacy and safety of the neoadjuvant treatment. Results: Between Feb 2010 and Sep 2014, 55 patients were enrolled in Japan and Korea. One patient with a jejunal GIST and one patient with PDGFRA-18 D842V mutation were excluded from analysis. Mean tumor diameter was 12cm (10-23). 86.8% of patients (46/53) completed neoadjuvant treatment. Dose reduction of imatinib was performed in 26.4% (14/53). The most frequent Grade 3 or 4 adverse events were G3 rash (5/53, 9.4%) and G3/4 neutropenia (4/53, 7.5%). Disease control rate (PR+SD) and response rate (PR) of neoadjuvant imatinib was 100% and 62.3% by RECIST, and 100% and 98.1% by Choi criteria, respectively. There was no case of CR or PD. 50 patients underwent operation, and R0 resection rate was 90.6% (n = 48, 95% CI 79.3% - 96.9%), which was significantly higher than the threshold value of 70% (p < 0.001). Combined resection of other organs (except gall bladder) was performed in 24.5% (n = 13), and 83.0% of patients (n = 44) could preserve ≥ 50% of the stomach. Postoperative complication occurred in 18.0% (9/50). Conclusions: Neoadjuvant imatinib treatment is effective and safe treatment option for a large primary GIST allowing high R0 resection rate with acceptable incidence of adverse events and postoperative complications. Clinical trial information: UMIN000003114.
Impact of comorbidity in the choice of curative treatment for esophageal cancer: A population-based study.
Authors: Faiz Zohra , Van Putten Margreet , Verhoeven Rob H.A. , van Sandick Johanna W. , Nieuwenhuijzen Grard A. P. , Lemmens Valery E. P. P. , Wijnhoven Bas P.L. , Plukker John Theodorus
Published: February 2017

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Background: Surgery after neoadjuvant chemoradiotherapy (nCRT) is the most common treatment with curative intent for esophageal cancer (EC) patients. Definitive chemoradiotherapy (dCRT) is an alternative for patients who are not eligible for resection because of comorbidity. The purpose of this retrospective study was to evaluate patient and tumor characteristics which are associated with the type of treatment. Methods: We selected all consecutive patients with a locally advanced EC (cT1 N + / T2-3N0-3M0-1a) who were treated with curative intent (nCRT, dCRT or surgery only) in the South East Netherlands between 1995 and 2013. For a proper assessment of the impact of co-morbidity, T4 tumors were excluded. The effect of co-morbidity on treatment decision and on survival was analyzed using a multivariable logistic regression and Kaplan-Meier method. Survival time was defined as time from 6 months after diagnosis until death or until January 1st 2015 for patients who were still alive. Results: Of the 1098 patients, surgery only was performed in 46%, nCRT in 28% and dCRT in 26%. Patients with ≥ 2 co-morbidities underwent more frequently dCRT (OR = 2.35; 95% CI: 1.45-3.86), or resection only (OR = 2.29; 95% CI: 1.41-3.69). Patients > 75 years (OR = 6.66; 95% CI: 3.48-12.77), patients with hypertension and diabetes (OR: 4.05;95% CI: 1.96-8.37-3.90) and patients with cardiovascular (mostly myocardial infarction) and pulmonary comorbidity (OR = 3:33; 95% CI: 1:51 to 7:34) underwent frequently more dCRT than nCRT. Patients with esophageal squamous cell carcinoma (ESCC) also had more frequently dCRT (OR = 2.27; 95% Cl: 1.38-3.73). Patients with an adenocarcinoma and ≥ 2 co-morbidities had favorable 3-year overall survival (OS) after nCRT compared with dCRT and surgery alone (p < 0.01). However, the 3-year OS after nCRT was similar after dCRT in ESCC patients with ≥ 2 co-morbidities (p = 0.75). Conclusions: The results of this study support the treatment with dCRT in patients with SCC of the esophagus, and with at least two co-morbidities, in particular, the combination of cardiovascular / pulmonary disorders and hypertension plus diabetes.