tbuckley/cabot-search huggingface dataset:
Phase II study: Neo-adjuvant chemotherapy (NAC) with fudr (F), leucovorin (L), oxaliplatin (O), and docetaxel (D) (FLOD) in chemo-naïve operable esophageal adenocarcinoma (EAC)
Authors: B. Ardalan, S. Spector, D. Mezentsev, M. A. Molina, I. Reis, P. Ganjei-Azar, M. Sapp, J. Rios, D. Franceschi, A. S. Livingstone
Journal: Journal of Clinical Oncology (2008)

15503 Background: A pathological complete response (pCR) to NAC, without the use of radiation therapy (RT), has not been previously reported in operable chemo-naïve stage III EAC. Toxicity profiles (TP) to FLOD are explored in this ongoing study. Methods: Patients (Pt), who had been diagnosed with operable stage III EAC, received 2 cycles of NAC. Each cycle consisted of a 30 min infusion of D (25 mg/m2), followed by F (110 mg/kg) and L (500 mg/m2) as a 24 hour infusion on Week (Wk) 1, 2 and 3. O (85 mg/m2) was infused over 2 hours on Wk 1 and 3. Wk 4 was rest. Dose reductions (DR) were allowed: 100 and 90 mg/kg for F, 20 and 15 mg/m2 for D and 65 mg/m2 only for O. NAC delays up to 2 Wk were allowed. EUS and PET/CT were performed prior and after NAC. Patients underwent surgical resection after 2 cycles of NAC. TP were graded per NCI CTCAE v. 3. The pCR rate is set as a primary endpoint. Results: 29 Pt, median age 63 (50–80), 23 males and 6 females were accrued. KPS ranged from 70 to 100. TP were: Grade 4: infection (Inf) 1 Pt; Grade 3: neutropenia (Ntr) 9 Pt, fatigue (Ftg) 7 Pt, diarrhea (Drh) 6 Pt, Inf 4 Pt; Grade 2: Drh (8), Ntr (7), Ftg (5), nausea (5), anemia (4); Grade 1: Drh, Ftg, mucositis, anemia, nausea. 23 Pt received G-CSF. 15 Pt had toxicity related delays during NAC. 10 Pt were admitted to hospital. DR was applied in 8 Pt. 3 Pt have died prior to surgery of causes not related to NAC and 1 Pt has progressed during NAC. 26 Pt have completed NAC, of whom 24 Pt (92%) underwent curative esophagectomy. Surgical pathology in 24 pts was as follows: pCR 4 Pt, pTx 3 Pt, pT1 1 Pt, pT2 6 Pt, pT3 9 Pt, pT4 1 pt. Nodes were positive in 12 (52.1%). 19 Pt were eligible for adjuvant chemotherapy (AC).13 Pt (68.4%) received AC. TP were: Grade 4 Ntr (1); Grade 3: Ftg (5), Ntr (3); Grade 2: Drh (5), Ntr (4); nausea (4), neuropathy (1); Grade 1: Drh, Ftg, Ntr, alopecia. 12 Pt received G-CSF. DR was applied in 2 Pt. Median follow-up is 9.3 months. Conclusions: FLOD has manageable TP. The pCR of 13.6% (95%CI: 2.9% - 34.9%) without RT and overall response rate of 48.1% (95%CI: 28.7% - 68.1%) is promising. We plan to continue to accrue Pt on this study. No significant financial relationships to disclose.
Observation versus adjuvant radiation or chemotherapy in the management of stage I seminoma.
Authors: M. S. Soper, J. R. Hastings, M. Tome, K. Lodin
Journal: Journal of Clinical Oncology (2011)

4596 Background: Controversy exists regarding the optimal management of stage I seminoma. This analysis defines the Kaiser experience over a 20-year period. Options after orchiectomy were observation vs. adjuvant radiation or chemotherapy. Methods: This is a retrospective study of 502 patients diagnosed with stage I seminoma from 1990-2010. All patients underwent orchiectomy. Outcomes examined were relapse-free survival (RFS), overall survival (OS), and cause-specific survival (CSS). Results: Of the 502 patients, 329 were treated with RT (113 to a pelvic/paraaortic field, 202 to a paraaortic field, and 14 to other fields), 79 had chemotherapy (33 had carboplatin x 1, 36 had carboplatin x 2, and 10 had other agents), and 94 were observed. Among the RT patients (median follow-up 7.5 y), there were 8 relapses and 12 deaths, of which 2 were deaths from seminoma. RFS was 97.6% and 97.2% at 2 and 5 years. Median time to relapse was 13.1 mos. Of the patients who relapsed, 6 were successfully salvaged with chemotherapy; 2 died of disease. OS was 99.6% and 98.0% and CSS was 99.6% and 99.3% at 2 and 5 years. Death from disease occurred at a median of 22.4 mos. Among the chemotherapy patients (median follow-up 2.6 y), there was 1 relapse at 14 mos and no deaths. Two-year RFS was 98.3% and OS and CSS were 100%. The patient who relapsed was successfully salvaged with BEP. Among the observation patients (median follow-up 5.2 y), there were 11 relapses, 3 deaths, and no deaths from seminoma. RFS was 89.2%, OS was 98.8%, and CSS was 100% at 2 and 5 years. Median time to relapse was 11.5 mos. Of the patients who relapsed, 6 were salvaged with RT and 4 with chemotherapy; all were NED at last follow-up. One patient is currently undergoing chemotherapy. RFS, OS, and CSS were compared via the log-rank test. There was no difference in OS or CSS among the groups. RFS was lower among observation patients (p < 0.001). Conclusions: Consistent with published trials, our data show that adjuvant radiation and chemotherapy yield similar outcomes in the management of stage I seminoma. Observation is a viable option that allows patients to avoid the toxicities of therapy. Our data confirm that while observation results in a lower RFS, patients who relapse can be salvaged, and OS and CSS are not affected.
A multidisciplinary quality improvement project to improve the safety of oral chemotherapy in hospitalized patients.
Authors: R. Alejandro Sica, Amer Sidani, Gelenis Calzadilla Domingo, Diana Sullivan, Katherine Sencion, Dominic Ho, Christina Haaf, Adam Bursua, Neeta K. Venepalli
Journal: Journal of Clinical Oncology (2016)

110 Background: At the University of Illinois Hospital and Health Sciences System (UIC), inpatient IV chemotherapy administration occurs in the setting of specific protocols and multidisciplinary safety assessments while oral chemotherapy agent (OCA) inpatient administration occurs less formally. Baseline 8 week review of 174 admissions to the oncology service revealed that of 16 patients (9.2%) on outpatient OCA, 50% received OCAs while inpatient, with 12. 55% having a formal chemotherapy note in place. We aimed to increase the percentage of administered OCAs with associated provider generated chemotherapy notes from 12.5% to 75% over 16 weeks. Methods: A multidisciplinary task force comprised of oncology providers, clinical pharmacy, nursing leadership, and information technology was assembled. An actual and ideal process map was created, and using tools such as affinity sorting and root cause analysis, interventions were implemented focusing on residents (knowledge of OCA), nurses (documentation and policy adherence), pharmacists (education, policy adherence) and IT team (order modification). A standardized multidisciplinary hospital wide process was implemented for OCA ordering, administration, documentation, and patient education. A novel REDCap (research electronic data capture) auditing procedure was designed by which a weekly pharmacy report of every oral chemotherapy order at UI Health is automatically generated. Results: Between June and September 2015, a total of 67 OCA administration reports were audited. OCA notes were associated with OCA administration in 58% of cases in June, 100% in July, 78% in August and 93% in September. Furthermore, OCA notes were entered within 4 hours of OCA ordering in 58% of cases in June, 54% in July and 78% of the cases in August and September. No adverse events were reported. Conclusions: At the University of Illinois Hospital and Health Sciences System, a multidisciplinary team designed and implemented a standardized OCA administration, ordering, and documentation process focused on safe, appropriate and timely inpatient OCA administration. A novel REDCap auditing process assisted the team to identify the areas in need of optimization.
Palliation of ulcerative breast lesions with radiation.
Authors: Prashant Vempati, Miriam Knoll, Kavita Vyas Dharmarajan, Sheryl Green, Amy Tiersten, Richard Lorne Bakst
Journal: Journal of Clinical Oncology (2015)

199 Background: Patients with advanced breast cancer may experience ulcerative breast lesions. Breast cancer with ulcerative lesions has been shown to severely affect a patient’s quality of life (QoL). The role of palliative radiation therapy (RT) in the management of ulcerative breast lesions needs to be further explored. Methods: IRB-approval was obtained to retrospectively review the radiation treatment records for all patients who underwent palliative RT for breast cancer at our urban academic medical center. A total of 13 patients were identified, and we herein report their demographics, treatment characteristics, and clinical outcomes. Results: The mean age of the patients receiving palliative RT for ulcerative breast cancer was 64 years. All patients had stage IV disease when they were evaluated for RT. All patients received prior systemic chemotherapy with a mean of four chemotherapeutic agents, the most common of which was Capecitabine. The mean radiation dose received for palliative RT was 27.54 Gy in 11 fractions with a median dose of 30 Gy in 15 fractions. Six (46%) of the patients received prior RT to the same breast, with a median dose of 59.5 Gy in 31 fractions. Among these six patients, the average interval between initial RT and ulcerative breast lesion was 69.5 months. The median overall survival in all patients since ulcerative breast lesion was 5 months and the mean survival did not differ between patients with previous history of RT and RT-naïve patients (4.50 vs. 4.57; p = 0.95). Six out of the 9 (69%) patients who received ≥ 30 Gy reported clinical improvement, whereas none of the 4 patients who received &lt; 30 Gy reported any benefit. There were no radiation-associated toxicities reported by patients. Conclusions: These data suggest that palliative RT ( ≥ 30 Gy) is an efficacious treatment for ulcerative breast cancer with minimal toxicity. Prior RT should not be a contraindication as patients with previous history of RT have similar outcomes compared to RT-naïve patients.
Toxicities and adherence rates of hormone treatment in male breast cancer patients treated at a tertiary care center
Authors: H. Visram, S. F. Dent
Journal: Journal of Clinical Oncology (2009)

e11613 Background: Male breast cancer (BC) comprises approximately 1% of all breast cancer cases, and over 80% of male BC tumours express the estrogen receptor (ER). Male BC patients (pts) are often offered hormonal treatment (HT) with tamoxifen (T), or more recently aromatase inhibitors (AI's). There is a paucity of information in the literature on the toxicities (Tx) and adherence rates of HT in this population. Methods: We conducted a retrospective chart review of 24 pts diagnosed with male BC at the Ottawa Regional Cancer Centre from 1986–2003. Data collected included pt age, ER status, progesterone receptor (PR) status, systemic chemotherapy, HT, and Tx of treatment. Results: Median age of 24 male BC pts was 70.0 years (r: 46–83 years). The majority (16/24) of pts had ER/PR testing: 12 (75.0%) ER/PR +, 1 (6.3%) ER +/PR-, 2 (12.5%) ER +/PR unknown, and 1 (6.3%) ER/PR-. Of the 15 pts who were ER +, 13 received T and 5 received anastrozole (A) monotherapy during their treatment. One ER - pt received adjuvant T. Three pts with ER status unknown received T. Median duration of treatment with T (17 pts) was 38.0 months (r: 2–79 months). Hot flashes (23.5 %) was the most common reported Tx. Decreased libido, weight gain, rash, and malaise were reported in 2 pts (11.8%) each. Increased liver enzymes, pulmonary embolism, and erectile dysfunction were reported in 1 pt (5.9%) each. Five pts (29.4%) terminated treatment early due to T toxicity (median treatment 15 months; r: 2–54 months). Five pts were treated with A (median 10 months; r: 3–60 months), 4 of whom received prior T treatment. One pt reported loss of libido, and 1 significant depression /suicidal ideation requiring psychiatric treatment. Conclusions: This study provides contemporary data on toxicities and adherence rates of HT in male BC pts in a non-clinical trial setting. Approximately 30 % of male BC pts discontinued T therapy due to Tx, potentially having a negative impact on clinical outcome. Future studies will examine differences in adherence rates and outcomes between T and A in male BC pts. No significant financial relationships to disclose.
Optimal extent of lymphadenectomy in gastric adenocarcinoma: A seven-institution study of the U.S. Gastric Cancer Collaborative.
Authors: Reese W. Randle, Doug S. Swords, Edward Allen Levine, Nora Fitzgerald, Malcolm Hart Squires, George A. Poultsides, Ryan C. Fields, Mark Bloomston, Sharon M. Weber, Timothy M. Pawlik, Linda X. Jin, Gaya Spolverato, Emily Winslow, Carl Richard Schmidt, David A. Kooby, David J. Worhunsky, Neil Saunders, Clifford Suhyun Cho, Shishir Kumar Maithel, Konstantinos Ioannis Votanopoulos
Journal: Journal of Clinical Oncology (2015)

115 Background: The optimal extent of lymphadenectomy in the treatment of gastric adenocarcinoma continues to be a subject of intense debate. We aimed to compare gastrectomy outcomes following limited (D1) or extended (D2) lymphadenectomy. Methods: Using the multi-institutional U.S. Gastric Cancer Collaborative database, we reviewed the morbidity, mortality, recurrence, and overall survival (OS) of 727 patients receiving D1 or D2 lymphadenectomies. Patients with stage IV disease, prior gastrectomy, and age 85 or greater were excluded. Multivariate analyses included variables with p values less than 0.1. Results: Between 2000 and 2014, 266 (36.6%) and 461 (63.4%) patients received a D1 and D2 lymphadenectomy, respectively. ASA class, mean number of comorbidities, grade, stage, and signet ring cell subtypes were similar between groups. Neoadjuvant and adjuvant chemotherapy was more common in the D2 group (p&lt;0.001). The mean number of lymph nodes recovered was significantly higher in patients receiving a D2 lymphadenectomy (21.5 for D2 vs. 17.1 for D1, p&lt;0.001). Median follow up was 1.3 years. While Clavien III/IV major morbidity was similar (15.0% for D1 vs. 14.5% for D2, p=0.85), mortality was worse for those receiving a D1 lymphadenectomy (4.9% vs. 1.3%, p=0.004). Recurrence rates for patients receiving D1 and D2 lymphadenectomies were 25.8% and 27.0%, respectively (p=0.74). D2 lymphadenectomy was associated with improved median OS in stage I (4.7 years for D1 vs. not reached for D2, p=0.003) stage II (3.6 years for D1 vs. 6.3 for D2, p=0.42), and stage III patients (1.3 years for D1 vs. 2.1 for D2, p=0.01). After adjusting for significant predictors of OS which included ASA, stage, grade, neoadjuvant chemotherapy, and adjuvant radiation, D2 lymphadenectomy remained a significant predictor of improved survival when compared with D1 lymphadenectomy (HR 1.5, 95% CI 1.1-2.0, p=0.008). Conclusions: D2 lymphadenectomy is associated with improved survival that is more prominent in early stages of disease. It can be performed safely without increased risk of morbidity and perioperative mortality and should be the preferred lymphadenectomy technique for the treatment of gastric adenocarcinoma.
TGF-beta polymorphisms in head and neck and lung cancer
Authors: V. G. Kaklamani, C. Oikonomopoulou, P. O’Keeffe, P. Oikonomopoulou, M. Sadim, B. Pasche, A. Argiris
Journal: Journal of Clinical Oncology (2005)

9687 Background: TGFBR1*6A is a hypomorphic allele of the type I transforming growth factor beta receptor (TGFBR1) that has been proposed as a cancer susceptibility allele for various malignancies. We have previously shown an increased risk for TGFBR1*6A carriers in developing breast, ovarian and colon cancer. TGFB1*CC has been associated with increased TGF-β signaling and decreased risk of breast cancer. Their contribution to head and neck and lung cancers and their association with smoking and alcohol patterns are unknown. Methods: Peripheral blood samples were collected from consecutive patients with head and neck or lung cancer and DNA was extracted from peripheral lymphocytes. Polymerase chain reaction amplification was followed by gel electrophoresis that allowed for the identification of the various TGFBR1 and TGFB1 genotypes. All subjects completed a detailed questionnaire on smoking and alcohol use and other social and family parameters. Our control group was derived from a previous pooled metaanalysis of 12 case-control studies. Results: 87 patients, 58 with lung cancer and 29 with head and neck cancer were analyzed. TGFBR1*6A was present in 16/87 patients, all but one heterozygotes (allelic frequency of 0.098), (10/58 in lung cancer and 6/29 in head and neck cancer patients). The allelic frequency of TGFBR1*6A in the healthy controls was 0.071. There was no significant association with smoking/alcohol use and TGFBR1 or TGFB1 genotypes. Conclusions: A higher allelic frequency of TGFBR1*6A was seen in patients with head and neck/lung cancers compared with the general population. TGFBR1*6A may predispose individuals to aerodigestive malignancies. No significant financial relationships to disclose.
Patient distress and survival in palliative radiotherapy.
Authors: Jacob Habboush, Robert P. Shannon, Laeticia Hollant, Megan Paige Single, Katherine Gaines, Bridget Smart, Steven J. Buskirk, Laura Vallow, Katherine S. Tzou, Stephen Ko, Jennifer Layton Peterson, Heather Biers, Atiya Day, Robert Clell Miller
Journal: Journal of Clinical Oncology (2016)

211 Background: Distress is known to be elevated in patients receiving cancer therapy, such as palliative radiotherapy (PRT). Many patients will experience distress during treatment and it is not always addressed in part due to a lack of guidance regarding the significance of distress. Methods: All RT patients in our clinic are asked to complete a patient reported distress (PRD) survey during treatment course. PRD forms consist of 30 categorical questions that assess distress subscales. Patients have the option to rate each question from 1 (low distress) to 5 (high distress). The survey also includes the National Comprehensive Cancer Network distress thermometer, which allows patients to rate overall distress level from 0 (no distress) to 10 (extreme distress). Patients’ records were retrospectively reviewed to abstract the needed information to assess survivorship. Results: 270 patients were included from 01/18/2012-08/07/2015. Overall PRD was analyzed as a continuous and a categorical variable (low: 0-3, moderate: 4-6, high: 7-10). Continuous and categorical variable PRD did not show a correlation of distress to survival (P = 0.26) and (P = 0.10) respectively. A correlation was noted in moderate distress category (RR: 1.51, P = 0.034), however, this was not noted in high distress category (RR: 1.25, P = 0.33). There was no statistical significant correlation with the adjusted variables. Patients with primary site of gastrointestinal cancer had worst prognosis (RR: 1.34, P: 0.14), while hematological origin had best prognosis (RR: 0.35, P: 0.038).Age had the strongest correlation with survival, as older patients receiving RT had poorer survival (RR: 1.13, P: 0.079). Conclusions: This study suggests that PRD is not predictive of survival in PRT. The primary goal of PRT is to improve quality of life (QoL) by assessing, anticipating and alleviating suffering; not necessarily improve survival. It also demonstrated that the most common stressors were related to reversible short-term side effects of RT such as fatigue and pain rather than long-term stressors related to daily activities and social measures which might affect QoL. It is imperative to explore assessment tools to mitigate suffering and improve strategies to enhance QoL in all medical disciplines.
Sunitinib therapy for patients with advanced renal cell carcinoma (aRCC): Analysis for safety and activity on single institution experience—Prolonged overall survival
Authors: D. E. Castellano, J. Sepulveda, I. Diaz Padilla, C. Coronado, E. Holgado, I. Garcia Escobar, F. DelaRosa, F. Villacampa, H. Cortes-Funes
Journal: Journal of Clinical Oncology (2008)

16119 Background: Sunitinib is a tyrosine kinase VEGFR and PDGFR inhibitor recently approved by the FDA for the treatment of aRCC. We reviewed all the record of pts enrolled in clinical trials, access programs and post-approval indication. Methods: pts with RCC histology, confirmed metastatic disease, PS: 0–3, adequate organ function and informed consent were analysed. Pts received treatment in repeated 6-wk cycles of 50 mg/day orally for 4 wks, followed by 2 wks off treatment. (at least complete 1 treatment-cycle for analysis). Efficacy was assessed by RECIST. Results: data for 84 pts were recorded, but more pts (17 pts) are still too early for efficacy assessment. Baseline characteristics (67 pts): PS 0–1: 83%; PS 2–3: 17%, median age 57 years (27–86); nephrectomy: 85%; clear-cell 84%, papillary-cell 9%, cromophobe-cell 5%. 2 or > mts sites: 87%. MSKCC 0: 47%, 1: 38%, 2: 15%. All pts were refractory to cytokine treatment. Median number of cycles was 7 (1−20+). The most important toxicity (NCIC 3.0, all pts) was g 3–4 thrombocytopenia in 14%, g 3–4 neutropenia in 7% and g 3–4 anemia in 5% of pts. Non-hematological toxicity was g 3 astenia 11%, g-3 mucositis 8%, g 3–4 hypertension 5%, g 3 hand-foot 5%. Dose-adjusted was performed in 29% of pts. Of 62 assesable pts, the overall response rate was 39.0% with 1 CR, 23 PR, 26 SD and 11 PD. (5 pts were not evaluable for response due to early progressive disease). With a median follow-up of 15 months the median PFS was 14,7 mo (95% CI: 9.5–19.3) and the OS was 27,6 mo (96% CI: 19.0–35.7). Conclusions: In our experience, Sunitinib a 50 mg/d 4 wks on/ 2 wks off, is well tolerated with a prolonged overall survival in this population (cytokine-refractory pts). Further analysis of prognostic factors, cost effectiveness and cytokine-naïve aRCC will be presented at ASCO. No significant financial relationships to disclose.
Risk-based outcome of childhood AML: Experience of National Guard Hospital, Jeddah, Saudi Arabia.
Authors: W. A. Jastaniah, T. M. Khattab, S. K. Felimban
Journal: Journal of Clinical Oncology (2010)

9575 Background: Risk stratification based on cytogenetics and percentage of bone marrow (BM) blasts after one course of chemotherapy influences outcome of childhood AML with event-free survival (EFS) and overall survival (OS) of 61% and 71%, 39% and 51%, and 35% and 35%; with chemotherapy for low-risk (LR), intermediate-risk (IR), and high-risk (HR), respectively, and EFS and OS of 50% and 61% for patients with unknown cytogenetics respectively (Horan JT et al. JCO 2008:26:5797-5801). Objectives:We analyzed the complete remission rate after one course of chemotherapy (CR), EFS, and OS in our center based on risk stratification. Methods: Patient files with childhood AML from 1985 to 2009 were reviewed for age, sex, CNS disease, BM cytogenetics, and CR rate to analyze EFS, and OS based on CR and cytogentic-risk. Results: There were 74 consecutive patients diagnosed with AML. AML-M3 were excluded (n = 5) and complete data for risk stratification were available in 50 patients. Mean age 6 years (range 0.7 – 14), Male: Female ratio 3.4:4, positive CSF 7/74 (10%), and BM cytogenetics were LR (n = 12); t (8;21) (n = 6) and inversion 16 (n = 6), IR (n = 15); normal cytogenetics (n = 3) and other translocation (n = 12), and HR (n = 3); monosomy 7, abn(3q), and complex cytogenetics (one each). Cytogenetics were unknown in 20 patients; failed (n = 4) and not done (n = 16). CR was achieved in 48/50 (96%) patients after course 1. Therefore, final risk stratification was as follows: LR (n = 12), IR (n = 14), unknown (n = 20), and HR (n = 4). Median follow-up duration 5 years. Table summarizes results. Conclusions: International risk- based stratification influenced outcome in our population. Patients with unknown cytogenetics had inferior outcome despite achieving CR post course 1. This highlights the importance of cytogenetic stratification. Targeted therapy and early stem cell transplant in high-risk patients may improve outcome further. Risk N = 50 CR post-course 1 EFS (%) OS (%) Low risk 12 (24%) 12/12 (100%) 8/12 (67%) 10/12 (83%) Intermediate risk 14 (28%) 14/14 (100%) 8/14 (57%) 9/14 (64%) Unknown cytogenetics 20 (40%) 20/20 (100%) 7/20 (35%) 7/20 (35%) High risk 4 (8%) 2/4 (50%) 1/4 (25%) 1/4 (25%) No significant financial relationships to disclose.