tbuckley/cabot-search huggingface dataset:
The impact of histologic tumor response on survival of patients treated with neoadjuvant mFOLFOX6 plus bevacizumab for the synchronous liver metastases from colorectal cancer.
Authors: Yu Katayose, Kazuyuki Ishida, Kei Nakagawa, Junichiro Yamauchi, Masaya Oikawa, Naoki Sakurai, Hiroaki Musha, Hiromune Shimamura, Koh Miura, Fuyuhiko Motoi, Shinichi Egawa, Michiaki Unno
Journal: Journal of Clinical Oncology (2014)

625 Background: The synchronous liver metastases (SLM) from colorectal cancer (CRC) have a poor prognosis. Therefore, we conducted a phase II study of neoadjuvant mFOLFOX6 + bevacizumab for SLM to explore the appropriate initial treatment (BeFORE study). Here, assess the impact of histological tumor response (HR) on the relapse-free survival (RFS) and the overall survival (OS). Methods: The main inclusion criteria of BeFORE study were SLM within 10 nodules and with measurable disease. The primary endpoint was the response rate (RR). The secondary endpoints included R0-liver resection rate, HR, RFS and OS. Patients (pts) were enrolled after R0-resection of the primary CRC and received 8 courses of mFOLFOX6 + BV (the first and last courses were mFOLFOX6 alone). After this neoadjuvant chemotherapy, pts underwent resection of liver metastases within 4-8 weeks. HR was re-assessed on the basis of the tumor regression grade (TRG) which evaluates the extent of fibrosis of tumor cells, and the modified TRG which evaluates the extent of fibrosis and therapeutic-associated necrosis, using resected tumor samples. Results: Between June 2008 and November 2010, 47 pts were enrolled and 44 pts were treated per protocol. The median number of metastases was 2 nodules, and the maximum diameter of tumors was 12.9 cm. The overall RR was 72.7%. Forty pts underwent liver resection and 39 pts had the R0-liver resection. Five pts (12.5%) of resected 40 pts achieved TRG 1-2 (major HR), 5 pts (12.5%) had TRG 3 (partial HR) and 30 pts (75.0%) had TRG 4-5 (no HR). 8 pts (20.0%) achieved mTRG 1-2, 8 pts (20.0%) had mTRG 3, and 24 pts (60.0%) had mTRG 4-5. With a median follow-up of 35 months, the 2-year RFS rate was 27.3% (the median RFS was 10.5 months), and the 2-year OS rate was 88.4%. Here, we perform sub-group analyses of RFS and OS by TRG, mTRG, respectively. Conclusions: The impact of HR (TRG, mTRG) on survival could help us with considering about the appropriateness of neo-adjuvant mFOLFOX6 + BV as the initial treatment for SLM. (This trial is on University hospital Medical Information Network-Clinical Trials Registry (UMIN-CTR); UMIN000001568.) Clinical trial information: UMIN000001568.
Projecting the Long-Term Quality-Adjusted Survival of Patients with Imatinib-Resistant Chronic Myelogenous Leukemia in Chronic Phase Receiving Nilotinib, Dasatinib, Dose Escalation Imatinib, or Palliative Care: An Essential Element for Cost-Effectiveness Analysis.
Authors: M. Botteman, J. Stephens, K. Carpiuc, W. Feng
Journal: Blood (2007)
Racial disparity trends in clinical presentation and outcomes in colorectal cancer: Findings from an urban university hospital.
Authors: E. P. Mitchell, A. Topham, R. Singla, S. Maron, J. Schoenfeld, F. Guiles, S. Goldstein, P. R. Anne, G. Isenberg, P. J. Maxwell
Journal: Journal of Clinical Oncology (2011)

518 Background: African Americans (AA) have a higher incidence and lower survival rates from colon and rectal cancer than Caucasian Americans (C). This disparity has been attributed to many factors, including diagnosis at later stage, unfavorable histopathologic features, inadequate treatment, and socioeconomic factors. The multidisciplinary management setting ensures similarity in management and treatment planning. In this study, we assessed the pathological features and evaluated survival outcomes in patients with CRC in AA and CA using a large single institutional database. Methods: We compiled data from 3,826 patients with colon and rectal cancer treated at Thomas Jefferson University Hospital from 1988-2009 and used Surveillance Epidemiology and End Results registry data from 1988-2004 to compare survival rates. Independent variables included age, racial background, site of primary tumor, degree of differentiation, stage at presentation, recurrence-free survival and overall survival rates for colon and rectal cancer and for each stage of disease. We compared survival rates using statistical modeling to account for differences in patient and disease characteristics between the two groups. Results: At diagnosis, AA pts presented with more advanced stage of disease (p &lt; 0.0001), were more likely to have proximal disease (p &lt; 0.000000528), had worse overall 5-year survival, and worse survival stage-by-stage than C patients. Data also showed that the odds ratio for risk of nodal involvement was greater for AA pts than C pts with lower T tumors. AA pts were more likely to have less well differentiated colon tumors, but more well differentiated rectal tumors, younger age and worse survival stage-by stage than C pts. Although C pts were more likely to have rectal cancer (p &lt; 0.0001), they were less likely to have stage IV disease at presentation. Conclusions: AA pts with CRC are more likely to present at a younger age with later stage, more proximal tumors, have higher nodal involvement with lower T lesions, and less well differentiated tumors than C. Additional studies on biological feature sand molecular markers are ongoing to and will be presented. No significant financial relationships to disclose.
Complete Clinical and Molecular Remissions Due to Very Effective GVL Reactions after Allogeneic Blood Stem Cell Transplantation for Mantle Cell Lymphoma in First or Second Remission.
Authors: Frank Schüler, William Krüger, Sandra Dölken, Herbert G. Sayer, Dietger W. Niederwieser, Gottfried Dolken
Journal: Blood (2007)
Patients with cancer and the network of multidisciplinary care: Harm or benefit?
Authors: J. Ewert, M. Luhmann, L. Hermann, U. Reich, A. Mehnert, M. De Wit
Journal: Journal of Clinical Oncology (2011)

e19660 Background: The multidisciplinary approach to cancer treatment generates multiple contacts between patients, nurses, physiotherapists and doctors from different disciplines. The psychological impact on patients treated by many different health professionals is not known. Our concern was to better understand the patients’ perspective on multidisciplinary treatment, its impact on psychological morbidity and patients’ role perception within the multidisciplinary team (MDT). Methods: This hypothesis-generating study was performed at the oncology ward of the Vivantes Klinikum Neukölln using the German version of the Hospital Anxiety and Depression Scale (HADS), the NCCN distress thermometer and an author generated questionnaire. The questionnaire was piloted in 23 patients and, after revisions, 118 patients were interviewed. Tumor stage, Karnofsky score and demographics were collected. Patients were separated into two groups based upon their role perception within the MDT: “I feel a part of the MDT” (n=92) and “I do not feel a part of the MDT” (n=24). Non-parametric statistical hypothesis tests and factor analysis were performed. Results: The 118 patients (57% male, median age 64 years) had mixed tumor diagnoses (65.5% oncological, 25.1% hematological). The group was relatively uncommon for psychosocial studies in oncology because only 3.4% had a breast cancer diagnosis. 66.7% of the patients had received palliative therapy at the time of the interview. There was a statistically significant difference in anxiety scores (HADS) between the two groups. Patients who felt integrated in the team also reported better communication and inclusion of their perspective in the management of their disease and indicated to have one constant contact person in the MDT significantly more often than patients who did not. Neither group was concerned about the number of specialists involved in their care. Conclusions: This exploratory study showed these cancer patients felt they were valued members of their MDT. A constant contact person could improve the integration of patients with the MDT and reduce anxiety. More research is required regarding the integration of patients in the MDT. The questionnaire will be further validated in other settings.
Symptom burden and change among adolescent/young adult (AYA) patients with breast, lung, colorectal, or prostate cancer.
Authors: V. T. Chang, F. Zhao, L. I. Wagner, S. D. Sanford, J. Salsman, M. Fisch
Journal: Journal of Clinical Oncology (2011)

9064 Background: Little is known about the symptoms experienced by AYA cancer patients (pts) with common solid tumors in outpatient adult oncology clinics. We compared AYA to cancer pts greater than 40 years old in a cohort by severity of cancer, treatment status, symptom burden, symptom changes, and difficulty in caring for them. Methods: In the ECOG E2Z02 Symptom Outcomes and Practice Patterns Study, pts with invasive cancer (ca) of the breast, prostate, colon/rectum, or lung were enrolled from multiple academic (n=6) and community sites (n=32). At study enrollment and 4-5 weeks later pts rated their symptoms on a 0-10 numerical rating scale with the MDASI-ECOG. Descriptive statistics, Fisher’s exact test, and logistic regression models were used to summarize the findings. Results: Of the 3106 evaluable pts, 168 (5.4%) were 40 years old or younger, and were more likely to be female (81.6% vs. 69.2%, P=0.001), and Hispanic (17.3% vs. 9.5%, P=0.001). There were 114 pts with breast ca (mean age 37.5 yrs, 25%-75% quartile 34.0-39.5), 44 colon ca( 36.2 yrs, 34.3-39.6), 9 pts with lung ca, and 1 with prostate ca. African-American pts were more likely to have advanced cancer at baseline (OR=1.40, 95% CI 1.07-1.83). Multivariate logistic regression analysis showed that AYA cancer pts were more likely to suffer moderate/severe fatigue (OR=1.62, 1.15-2.29), distress (OR=1.82, 1.19-2.78), drowsiness (OR=1.82, 1.31-2.51), cognitive difficulties (OR=1.68, 0.98-2.89) and hair loss (OR=1.55, 1.03-2.33). While the number of symptoms was similar, interference with function was more severe for AYA cancer pts for mood (OR=1.61, 1.11-2.34) and relations with others (OR=1.93, 1.24-2.98). Symptoms were less likely to improve in AYA pts, and this reached significance for distress (OR=0.56, 0.33-0.95). There were no significant differences in cancer stage, current treatment status and clinician’s perception of difficulty in caring for AYA cancer pts. Conclusions: AYA cancer pts with primarily breast and colon ca report higher symptom severity and less improvement for many common symptoms compared to older cancer pts. These data provide direction in developing supportive care programs for AYA cancer pts.
Clinical outcomes in focal versus extensive micropapillary bladder cancer at the time of diagnostic transurethral resection.
Authors: Daniel Levi Willis, Mario Fernandez, Rian J. Dickstein, Charles Guo, Bogdan Czerniak, Sahil Parikh, Jay Bakul Shah, Louis L. Pisters, H. Barton Grossman, Colin P.N. Dinney, Ashish M. Kamat
Journal: Journal of Clinical Oncology (2013)

317 Background: It has been postulated that the outcome of patients with micropapillary bladder cancer (MPBC) is dependent on the extent of MPBC component relative to conventional urothelial carcinoma. Herein, we reviewed the clinical outcomes of patients with MPBC and evaluated the outcomes based on extent of disease in the transurethral resection (TUR) specimen. Methods: An IRB-approved institutional review of our bladder cancer database identified 255 patients with MPBC. Dedicated GU pathologists at our institution quantified MPBC as being "focal" or "extensive" in 201 patients, who form the basis of this report. Univariate analysis was performed with the chi square test and the Kaplan-Meier estimator, while multivariate analysis was performed using Cox Regression analysis. Results: Overall, 127 (63%) patients were reported as having focal MPBC and 74 (37%) patients had extensive micropapillary histology. Survival analysis demonstrated that patients with focal MPBC had a greater overall median survival of 54 mo. vs. 22 mo. for those with extensive MPBC (p=0.002). The extent of MPBC also correlated with cT stage as extensive MPBC was seen with higher stage disease (p=0.035). When stratified by cT stage, patient survival correlated with the extent of MPBC such that median survival for focal versus extensive MPBC was 122 vs. 62 mo. for cT1 (p=0.04), 54 vs. 22 mo. for cT2 (p=0.008), and 12 vs. 4 mo. for cT3 patients (p=0.017). In the cT1 cohort, patients with extensive MPBC were 2.3 times more likely to have disease progression on BCG therapy than those with focal disease (p=0.02). Extensive MPBC in the TUR specimen was also associated with higher rates of clinical lymph node metastasis (34% vs. 19%, p=0.018). The association of the extent of MPBC with overall survival remained significant after multivariate analysis with other prognostic variables including lymphovascular invasion and clinical T stage (p=0.05). Conclusions: The extent of micropapillary architecture in the TUR specimen is associated with stage of tumor at presentation. However, even when controlling for stage, patients with "extensive" MPBC on TUR specimen have independently worse outcomes compared to those with focal MPBC.
Single-institution experience with sorafenib for hepatocellular carcinoma (HCC) in the post-liver transplant setting (Ltx).
Authors: Elizabeth Ann Mariano, Venu Gopal Bathini, Graham Barnard, Nadeem Anwar, Adel Bozorgzadeh, Reza Saidi, Nicholas Jabbour, Angela D'Antonio, Curtis Barry, Bradley Alan Switzer
Journal: Journal of Clinical Oncology (2013)

237 Background: Sorafenib plays a role in the treatment of advanced HCC; however its role after Ltx has not yet been defined in the adjuvant setting. Patients at high risk for HCC recurrence, or those with recurrence after Ltx may benefit from this therapy. Methods: We present our institution’s experience of the use of sorafenib in the post Ltx setting in 11 patients. High risk for HCC recurrence (9 patients) was defined as vascular invasion, lymphovascular invasion, liver capsule invasion, or &gt;3 tumors present in the liver explant. 2 patients had recurrent HCC post Ltx. The starting dose of sorafenib varied, but was most commonly 200mg po BID. Patients were seen monthly while on sorafenib, and 4-phase liver CTs or MRIs were performed every 3 months. Results: Median age at Ltx was 55 (range 48-77). Median time between Ltx and start of sorafenib was 150 days (range 30-543). Reasons for sorafenib use were high risk of recurrence 8/11 (72.7%), recurrence 2/11 (18.2%), rising AFP 1/11 (9%). Median duration of therapy was 152 days (range 21-295). Only 1/9 (11%) of patients could not complete 6 months of adjuvant therapy due to toxicity. 2 patients have yet to comple 6 months of adjuvant sorafenib. All 9 patients receiving therapy for high risk of recurrence are alive with longest survival of 40 months. Both patients with recurrent disease have died. Toxicity:36% (4 patients) had Grade 2 or 3 hand foot syndrome, 18% (2 patients) had grade 1 diarrhea and hypertension, 9% (1 patient) had grade 3 elevation in liver function tests, 9% (1 patient) had grade 3 parasthesias. Other side effects include grade 2 nausea (1 patient); grade 2 muscle weakness (1 patient), grade 1 lightheadedness (1 patient), grade 1 hair loss (1 patient), and grade 1 LFT elevation (1 patient). Zero patients reported no toxicity. Conclusions: Sorafenib in the post Ltx setting was well tolerated with manageable toxicities. The majority of patients at high risk for recurrent HCC were able to complete 6 months of adjuvant therapy. Further studies investigating this therapy in post transplant patients are warranted.
Evaluation of epidermal growth factor receptor <i>(EGFR)</i> mutations and gene copy numbers as predictors of clinical outcomes in Japanese patients with recurrent non-small-cell lung cancer (NSCLC) receiving gefitinib
Authors: T. Takano, Y. Ohe, T. Yoshida, K. Tsuta, Y. Matsuno, N. Yamamoto, I. Sekine, H. Kunitoh, S. Hirohashi, T. Tamura
Journal: Journal of Clinical Oncology (2005)

7032 Background: Recent reports have suggested that somatic mutations in the EGFR tyrosine kinase domain and EGFR gene amplifications are associated with gefitinib sensitivity in patients (pts) with NSCLC. To evaluate the predictive values of these factors, we studied consecutive pts with NSCLC who relapsed after surgery and received gefitinib in our hospital. Methods: Surgical specimens were analyzed in 66 pts who had been treated with gefitinib (250 mg/day) between July 2002 and May 2004. Direct sequencing of exons 18–24 of EGFR was performed to detect mutations, and quantitative real-time PCR was performed to analyze the EGFR gene copy number using DNA extracted from laser-captured tumor cells. Results: All the pts were Japanese; median age: 65 (32–80) years; female/male: 26/40; adenocarcinoma (Ad)/others: 62/4; never/former/current smokers: 31/12/23; prior chemotherapy (yes/no): 29/37. Thirty-nine pts (59%) had EGFR somatic mutations; 20 pts had deletions in exon 19, 17 pts had point mutations (L858R) in exon 21 and 2 pts had point mutations (G719S or G719C) in exon 18. Four pts had minor secondary mutations in exons 18 or 20. EGFR mutations were seen in 69%/53% of the female/male pts, 68%/83%/35% of never/former/current smokers, 73%/50% of Ad pts with/without predominant papillary growth, and 72%/27% of Ad pts with/without BAC feature. EGFR gene amplification (≥3/cell) was observed more frequently in pts with EGFR mutations than in pts with wild-type EGFR (56% vs. 26%), and high-level amplification (≥6/cell) was observed only in pts with EGFR mutations (33% vs. 0%). CR/PR/SD/PD were observed in 2/29/4/1 pts with EGFR mutations and in 0/3/5/14 pts with wild-type EGFR. The response rate was higher (84% vs. 11%), the time to progression (TTP) was longer (median TTP: 12.6 vs. 1.7 months), and the overall survival (OS) was longer (1-y OS: 80% vs. 47%) in pts with EGFR mutations. Other factors, including the EGFR gene copy number, were not independent predictors of clinical outcomes. Conclusions: EGFR mutations are frequently detected in Japanese patients with NSCLC and strongly predict gefitinib sensitivity. No significant financial relationships to disclose.
Two bi-institutional prospective studies using intraperitoneal oxaliplatin with or without irinotecan during HIPEC following complete cytoreductive surgery for colorectal carcinomatosis.
Authors: F. Quenet, D. Goéré, S. Mehta, L. Roca, F. Dumont, M. Essissen, B. Sain-Aubert, D. Elias
Journal: Journal of Clinical Oncology (2011)

486 Background: In treatment of peritoneal carcinomatosis (PC) of colorectal origin, studies combining cytoreductive surgery (CRS) and hyperthermic intra-peritoneal chemotherapy (HIPEC) have shown encouraging survival results. Intraperitoneal drugs usually used are mitomycin C or oxaliplatin in monotherapy. The aim of this study was to assess long-term survival in patients treated with a new combination of oxaliplatin and irinotecan (ox-irino) and to compare it with that obtained with oxaliplatin alone (ox-alone). Methods: Two bi-institutional prospective studies were carried out. All patients with PC who had undergone CRS with HIPEC using either ox-alone 460 mg/m 2 or ox-irino (ox: 300 mg/m 2 and irino: 200 mg/m 2 ) from January 1998 to December 2007 were included. Results: 146 patient underwent CRS + HIPEC for PC from colorectal carcinoma. 103 patients received ox-irino and 43 patients received ox-alone HIPEC. The overall mortality rate was 4.1%. The overall morbidity rate was 47.2%. It was significantly lower in the ox-alone group compared to the ox-irino group (34.9% vs. 52.4%, p =0.05). After a median follow-up of 48.5 months, (95%CI 41.0-56.3), the median OS was 41 months (95%CI 32-60) and the median RFS was 15.7 months (95%CI 12-18). The median RFS of the ox-alone group was 16.8 months (95%CI 11-25) and was not significantly different from that of ox-irino group (15.7 months, 95%CI 11-18, p = 0.93). There was no significant difference between the median OS of the ox-alone group (40.83 months, 95%CI 29–61) and the ox-irino group (47 months, 95%CI 32-61, p = 0.94). At 5 years, the OS and the RFS rates were respectively 41.8% (95% CI 25.20-57.58) and 13.8% (95% CI 4.66-27.84) in the ox-alone group and 42.4% (95% CI 28.52-56.09) and 14.2% (95% CI 6.27-25.20) in the ox-irino group. Conclusions: This study confirms the interesting survival results of CRS + HIPEC to treat colorectal PC. 460 mg/m 2 of oxaliplatin alone HIPEC is as efficient as 300 mg/m 2 of oxaliplatin associated with 200 mg/m 2 of irinotecan, but with lower morbidity. Ox-alone HIPEC, should remain the current gold standard. No significant financial relationships to disclose.
Differences in expectations of clinical trials between patients who participate in clinical cancer trials and those who do not
Authors: S. J. Wei, M. K. Hampshire, P. A. Devine, J. M. Metz
Journal: Journal of Clinical Oncology (2005)

6065 Background: Differences in expectations of clinical trials in patients who have enrolled (trial patients, TP) and those who have not enrolled (non-trial patients, NTP) may limit the ability to apply results of clinical trials to the general population. Understanding these differences may help identify barriers to clinical trial enrollment and increase recruitment. Methods: A piloted questionnaire assessing basic demographics and expectations of clinical trials was offered through the OncoLink website (www.oncolink.org) and two radiation oncology clinics. The questionnaire was completed by 605 patients (140 TP (23%) and 465 NTP (77%)), and comparisons were made between the two groups. Results: There was no difference with regards to age, gender, race, or site of primary cancer for TP compared to NTP. Although 89% of NTP stated they were interested in exploring enrollment in clinical trials, 66% never had discussions about trials with their physicians. TP were more likely to obtain information about clinical trials from healthcare professionals (67% vs. 44%, p<0.001) and from other patients (26% vs. 14%, p=0.001). There was no difference in the likelihood of obtaining this information from news media (p=0.75) or the Internet (p=0.39). The majority of TP (85%) felt it was very likely or somewhat likely they would benefit from enrollment; 86% did not feel they were very likely to experience toxicity. 77% of TP indicated they would need at least a 10% chance of benefit from a clinical trial in order to enroll on that trial, compared to 84% of NTP (p=0.04). There was no difference with regards to maximal chance of serious toxicity that was acceptable to enroll on a trial. Conclusions: The majority of NTP were interested in exploring clinical trials, but most were not informed of available studies. TP were less likely to require a high probability of benefit in order to enroll in a clinical trial. Differences in expectations of clinical trials may act as a barrier to clinical trial enrollment. Improving patient education about clinical trials, increasing access to other patients on trials, and providing reasonable expectations of clinical trials may improve clinical trial enrollment. No significant financial relationships to disclose.