tbuckley/cabot-search huggingface dataset:
Adjuvant pelvic radiation therapy and high dose rate brachytherapy for pathologic stage III endometrial cancer
Authors: S. Patel, L. Portelance, J. Arseneau, G. Stanimir
Journal: Journal of Clinical Oncology (2005)

5157 Background: There is a paucity of data regarding the use of adjuvant external beam radiotherapy (RT) and high dose rate (HDR) brachytherapy in the treatment of patients with stage III endometrial cancer. Methods: A retrospective review of 40 pathologic FIGO stage III endometrial cancer patients treated between 1996 and 2003 at McGill University was performed. Patients with papillary serous and clear cell carcinomas were excluded. All patients underwent surgery followed by adjuvant RT. Nodal sampling was performed in 25 patients (63%). External beam RT of 45 to 50.4 Gy in 23 to 28 fractions was delivered to the whole pelvis in all patients and with extended fields in one patient (5%) with positive para-aortic nodes. HDR brachytherapy of 6 to 18 Gy in 1 to 3 fractions was delivered to the vaginal vault in 30 patients (75%). Results: Median age at diagnosis was 58 years. Patients had stage IIIA disease in 24 cases (60%), stage IIIB in 2 cases (5%), and stage IIIC in 14 cases (35%). Tumors were histologic grade one in 11 patients (28%), grade two in 15 patients (38%), and grade three in 14 patients (35%). Lymphatic and vascular space involvement was present in 13 patients (33%) and 25 patients (63%), respectively. Five-year actuarial disease-free survival was 52% and 5-year actuarial overall survival was 53%. Local (pelvic) failures occurred in 10 patients (25%), including distal vaginal failures in 2 patients (5%), central pelvis failure in 1 patient (3%), and lateral pelvis (side wall or pelvic nodal) failures in 6 patients (15%). Distant failures occurred in 6 patients (15%), including abdominal failures in 4 patients (10%). No local failures and only one distant failure (3%) were observed in patients without vascular space involvement. Acute adverse events were observed in two patients (5%) who developed RTOG grade 3 genitourinary toxicity. One patient (3%) developed late RTOG grade 4 gastrointestinal toxicity. No treatment-related deaths were observed. Conclusions: Adjuvant pelvic RT and vaginal vault HDR brachytherapy is effective and well tolerated in the treatment of patients with stage III endometrial cancer. No significant financial relationships to disclose.
Does anesthesia type influence breast cancer outcomes?
Authors: Abraham Tsigonis, Jeffrey Landercasper, Mohammed Al-Hamadani, Jared Linebarger, Choua Vang, Edward Marchese, Forest Krause, Jeanne Johnson, Kristen Marcou, Jane Hudak
Journal: Journal of Clinical Oncology (2013)

66 Background: Surgery maintains a central role in the local treatment of Stage 0-III breast cancer. Recent studies suggest patient immunity is altered by general anesthesia (GA), potentially worsening cancer outcomes. A single retrospective case review has concluded that breast cancer patients receiving regional anesthesia with paravertebral block (PVB) anesthesia had better cancer outcomes compared to patients receiving GA, but these conclusions have not been validated. We hypothesized that local regional anesthesia (LRA) would be associated with better cancer outcomes compared to GA. Methods: We performed a retrospective review of Stage 0-III breast cancer patients undergoing surgery in a single center during a nine year period ending 1/1/2010. Patients undergoing neoadjuvant therapy or major flap reconstruction were excluded. Data regarding patient, tumor and treatment factors known to influence cancer outcomes were collected. Overall survival (OS), disease free survival (DFS), local regional recurrence (LRR), and ipsilateral breast tumor recurrence (IBTR) were calculated by Kaplan-Meier method with Log-Rank comparison. Results: We analyzed 1,107 patients. Median age was 64 years (range 24-97). Median and longest follow-up were 5.5 and 12.5 years. GA was utilized for 461 (42%) patients, and 646 (58%) received LRA. Initial operation was breast conserving in 796 (72%) and mastectomy in 311 (28%). Forty two patients died from breast cancer (crude mortality 3.8%). LRR occurred in 34 patients (3%). LRA was used more than GA in patients with lower grade and stage, smaller tumors, positive hormone receptor status, and negative nodal status (p&lt;0.001). We identified no differences in OS, DFS, LRR or IBTR in comparison of GA to LRA. Conclusions: Type of anesthesia for breast cancer surgery did not affect cancer outcomes in our institution. This result differs from the only prior published clinical report on this topic.
A pooled analysis of the efficacy and safety of sunitinib in elderly patients (pts) with metastatic renal cell carcinoma (mRCC).
Authors: T. E. Hutson, R. M. Bukowski, B. I. Rini, M. E. Gore, J. M. G. Larkin, R. A. Figlin, C. H. Barrios, B. Escudier, X. Lin, K. D. Fly, B. Martell, E. Matczak, R. J. Motzer
Journal: Journal of Clinical Oncology (2011)

4604 Background: Sunitinib is approved multinationally for mRCC treatment (Tx), with demonstrated activity and tolerability in both the first- and second-line Tx settings. Here, we report a retrospective analysis of the efficacy and safety of sunitinib as a function of age in pts with mRCC from 6 clinical trials. Methods: Analyses included pooled data from 1,059 pts who received single-agent sunitinib on the approved 50 mg/d 4-week-on/2-week-off schedule (n=689; 65%) or at 37.5 mg continuous once-daily dosing (n=370; 35%), in both the first- (n=783; 74%) and second-line (n=276; 26%) Tx settings. Median progression-free survival (PFS) and overall survival (OS) were estimated by Kaplan-Meier method and compared between pts <70 vs. ≥70 yrs of age by log-rank test. Adverse event (AE) rates were also compared. Results: Of 1,059 pts, 857 (81%) were of age <70 yrs and 202 (19%) ≥70 yrs, with median ages of 57 and 73 yrs, respectively. 73% and 59% were male, but otherwise baseline characteristics were similar. Median PFS was similar in both groups (9.0 vs. 10.9 mo; HR, 0.85; 95% CI, 0.70–1.02; P=0.0830), as was median OS (23.3 vs. 23.7 mo; HR, 0.94; 95% CI, 0.76–1.15; P=0.5441). In addition, efficacy was similar by age regardless of Tx setting. In first-line pts <70 vs. ≥70 yrs, median PFS and OS were 9.9 mo (95% CI, 8.3–10.7) vs. 11.0 mo (95% CI, 9.0–14.7) and 23.5 mo (95% CI, 21.1–27.6) vs. 25.5 mo (95% CI, 21.6–38.4); in second-line pts, median PFS and OS were 8.1 mo (95% CI, 7.8–8.7) vs. 8.4 mo (95% CI, 6.3–14.2) and 20.1 mo (95% CI, 16.2–25.0) vs. 15.8 mo (95% CI, 13.7–23.9). Most Tx-emergent AEs occurred at similar rates in both age groups; however, some AEs were significantly less common in pts aged <70 vs. ≥70 yrs, including fatigue (59% vs. 69%), decreased appetite/weight (29% vs. 53%), cough (20% vs. 29%), peripheral edema (17% vs. 27%), anemia (17% vs. 25%), and thrombocytopenia (16% vs. 25%; all P<0.05). Hand–foot syndrome was more common in younger pts (32% vs. 24%; P<0.05). Conclusions: In pts with mRCC, the efficacy of sunitinib was comparable in the elderly population, deriving similar benefit as younger pts regardless of Tx setting. The AE profiles were also similar, although some AEs were more common in elderly pts.
Phase II trial of gemcitabine + cisplatin + ipilimumab in patients with metastatic urothelial cancer.
Authors: Matt D. Galsky, Noah M. Hahn, Costantine Albany, Mark T. Fleming, Alexander Starodub, Przemyslaw Twardowski, Sumanta K. Pal, Ralph J. Hauke, Guru Sonpavde, William K. Oh, Nina Bhardwaj, Sacha Gnjatic, Seunghee Kim-Schulze, Ziyue Liu
Journal: Journal of Clinical Oncology (2016)

357 Background: Immune checkpoint blockade, with anti-PD-1/PD-L1 antibodies, has shown striking results in patients (pts) with mUC. While CTLA4 blockade has demonstrated pharmacodynamic effects in localized bladder cancer (Carthon, Clin Can Res, 2010), the role of CTLA4 blockade in mUC remains undefined. We hypothesized that chemotherapy may lead to immunogenic cell death, and other immunomodulatory effects, which could subsequently be exploited with the addition of ipilimumab. Methods: Pts with mUC received 2 cycles of gemcitabine + cisplatin (GC) alone followed by 4 cycles of GC + ipilimumab (GCIpi). The primary endpoint was % of patients alive at 1 year. Secondary endpoints included safety, objective response rate, and progression-free survival. Immune monitoring was performed at baseline, after GC alone, and after GCIpi. Results: 36 pts with mUC (median age 60; range: 33-80) were enrolled; KPS was 80%, 90% and 100% in 30%, 45%, and 25%; 58% had visceral metastases and 20% had liver metastases. Pts received a median of 5 cycles of GC (range: 1-6) and 3 doses of Ipi (range: 1-8). The most common grade 3-4 adverse events were neutropenia (36%), thrombocytopenia (19%), anemia (25%), hyponatremia (31%), thromboembolism (11%), and renal insufficiency (19%). The most common grade 3-4 immune-related adverse events were colitis (6%), hypophysitis (3%), hyperthyroidism (1%), and rash (1%). The objective response rate is shown in the Table. Median progression-free survival is 8 months (95% CI 6.2-9.8 months). Median follow-up is 10.4 months (range: 2.8-35.3 months). The primary endpoint analysis will be mature for the meeting. GC alone had no significant impact on circulating immune cell subsets; Ipi significantly expanded circulating CD4 and CD8 T cells. Conclusions: A phased schedule of GC plus immune checkpoint blockade was feasible in pts with mUC. Ipi induced immunomodulatory effects despite concurrent chemotherapy. Survival data are not yet mature. Ongoing analyses are exploring the impact of GC alone, and GCIpi, on antigen-specific T cell immunity and correlating such findings with “outlier” survival times. Clinical trial information: NCT01524991. [Table: see text]
Gemcitabine and carboplatin in the treatment of transitional cell carcinoma of the urothelium
Authors: E. Hudson, J. F. Lester
Journal: Journal of Clinical Oncology (2008)

16136 Background: In advanced transitional cell carcinoma (TCC) of the urothelium gemcitabine plus cisplatin (GC) is considered a gold standard chemotherapy regimen. However, treatment with cisplatin is associated with significant toxicity and requires intravenous hydration. Carboplatin is an analogue of cisplatin which at standard doses is less toxic, and does not require hydration. From July 2003 to June 2007, 15 consecutive patients with metastatic TCC of the urothelium were treated with gemcitabine plus carboplatin (GCarbo). Patients were not selected on the basis of poor renal function, poor performance status (PS) or any other adverse feature. Methods: All cases of metastatic TCC of the urothelium referred to a single consultant at Velindre Cancer Centre, South East Wales from July 2003 to date were treated using 3-weekly cycles of gemcitabine 1,200 mg/m2 i.v. days 1 and 8 plus carboplatin AUC 5–6 i.v. day 1. Creatinine clearance was estimated using the Cockroft-Gault formula. Carboplatin dose was calculated using the Calvert formula. All patients were required to have a histological diagnosis of TCC. Survival was calculated from the start of chemotherapy to the date of last contact or death using the Kaplan-Meier method. Treatment was continued for up to 6 cycles. Granulocyte-colony stimulating factors were not routinely used. Patients were transfused if the haemoglobin fell below 9g/dl, or if significant symptoms developed. Results: The median age of all patients was 67 years. In 10/15 (67%) patients the urinary bladder was the primary site. All patients had stage 4 disease. In total, 4/15 (27%) patients had a PS of 0, 8/15 (53%) patients had a PS of 1 and 3/15 (20%) had a PS of 2. Grade 3 or 4 toxicity included neutropenia (47%), anaemia (27%) and thrombocytopenia (20%). Red blood cell transfusions were given to 6/15 (40%) patients. No platelet transfusions were given. No patients required admission for neutropenic pyrexia/sepsis, and there were no treatment-related deaths. The overall response rate was 67%. The median survival was 9 months (95% CI 7.4–10.6), and 1-year survival 42%. Conclusions: GCarbo is well tolerated, and has activity as first- line treatment in metastatic TCC of the urothelium. Results are comparable to other studies using this regimen. No significant financial relationships to disclose.
Identification of quality care standards and development of indicators in oncology.
Authors: Carlos Camps-Herrero
Journal: Journal of Clinical Oncology (2014)

239 Background: Continuous assessment of clinical practice is a fundamental strategy for improving quality care. The generation of indicators in the context of clinical practice standards is the key factor for its success. The purpose of this work is to identify and establish standards in medical care of patients with breast, lung and colon cancer and to develop their indicators. Methods: The project was performed in 4 cycles: (1) Identification of clinical care standards for patients with lung, colon and breast cancer through research for scientific evidence. It was structured in four stages: diagnosis and treatment for every cancer and organisation of palliative care services at the end of life, equal for all three groups. (2) Revision of standards by an expert group of 9 oncologists. (3) Selection of standards for the generation of the indicators using the Delphi method, modified by a panel of experts consisted of 39 oncologists. (4) Development of indicators for the selected standards. Results: During the first revision 98 recommendations and standards were approved and selected by the group of experts and presented to the second panel of experts. Finally through the Delphi method 50 standards were selected, applicable to national level. For each one of the 50 standards an indicator was formed, 10 indicators for the organisational stage, 10 for the palliative care and 10 indicators specific for the diagnosis and treatment of each one of the cancer groups (colon, breast and lung). Conclusions: A total of 50 indicators were generated as measurement of parameters related to the quality of clinical practice and the organisation of care for patients with breast, colon and lung cancer. Their use is fundamental in identifying areas for improvement that will allow the identification of future strategies of quality care.
Invasive breast carcinoma in women ≤ 35 years: Clinical features, prognostic factors and clinical outcome related to hormone receptor status and Her2/neu expression
Authors: F. E. Petracci, R. D. Chacón
Journal: Journal of Clinical Oncology (2008)

11524 Background: The objective of this study was to identify the prognostic factors of recurrence and death in patients ≤35 years with invasive breast carcinoma (IBC) and to assess the clinical features and outcomes by analyzing three subgroups: 1) estrogen (ER+) and/or progesterone positive receptor (PR+), Her2/neu negative (HR+/Her2/neu-), 2) ER or PR±/Her2/neu positive (HR±Her2/neu+) and 3) both HR and Her2/neu negative (3N). Methods: Data were collected from 175 patients ≤35 years diagnosed with IBC at our institution from November 1999 to December 2007.The log-rank test and multivariable Cox regression analysis were used to determine independent factors associated with survival and recurrence. Results: The mean age was 31.5 years (range 18–35). Size was < 2cm in 52%, 57% were lymph node positive and 8% were initially diagnosed as stage IV. 66% presented with ER+, 65% with PR+ and 32% were Her2/neu+. Conservative breast surgery and lymph node dissection were performed in 70% and 82%, respectively. 90%, 80% and 59% received adjuvant chemotherapy (CT), radiotherapy and hormone therapy (HT), respectively. The median follow-up was of 34 months (range 1–184). 7% of patients developed secondary breast cancer, 17% local recurrences, 25% distant recurrences and 19% died. Positive lymph node was a prognostic factor of overall recurrence (HR 4.79, p=0.002) and death (HR 11.9, p=0.02). Her2/neu overexpression or amplification increased the overall recurrence chance (HR 2.90, p=0.04). The adjuvant HT decreased the overall recurrence (HR 0.15, p=0.0002) and death chance (HR 0.2, p=0.02). Adjuvant CT significantly decreased the risk of death (HR 0.03, p=0.03). The comparative analysis among subgroups did not show significant differences at diagnosis, as well as in the number of secondary breast cancer (p=0.75), recurrences (p=0.35) or deaths (p=0.46). We have noticed a trend to more local recurrences and deaths in HR±/Her2/neu+ and 3N tumors. Conclusions: Lymph node metastases were the most important prognostic factor of recurrence and death in patients with IBC ≤35 years. The risk of recurrence and death was significantly decreased by adjuvant hormone therapy, as well as the risk of death was decreased by adjuvant CT. No significant financial relationships to disclose.
Everolimus (E) versus axitinib (A) as second-line therapy (2L) in metastatic renal cell carcinoma (mRCC): Retrospective experience at Gustave Roussy.
Authors: Annalisa Guida, Laurence Albiges, Yohann Loriot, Christophe Massard, Karim Fizazi, Bernard J. Escudier
Journal: Journal of Clinical Oncology (2016)

527 Background: Currently both E and A are standard treatments for patients (pts) with mRCC after failure of first line therapy (1L)with VEGF-targeted therapy. There is no comparative study reported so far, and this study aims to evaluate these 2 drugs in a large center. Methods: Patient characteristics, safety and outcome data from all mRCC pts who received E or A as 2L at Gustave Roussy from April 2007 to May 2015 have been compared. Progression-free Survival (PFS) and Overall Survival (OS) were assessed by the Kaplan-Meier method and compared with the log-rank test. Results: 81 pts were treated with E and 45 pts with A. The table shows patient characteristics. The 2 groups were similar. The most common 1L was sunitinib (79% in E group and 82.2% in A group). Median follow up was 29 mo (95%CI 26 – 31), 26 mo for A and 33 mo for E (p=0.046). Median OS was 21.5 mo for E and 14.9 mo for A (p = 0.23). Median PFS was 5.3 and 7.7 mo for E and A respectively (p = 0.39). Disease control rate was 69% and 73% (p=0.31) and partial response was achieved in 4% and in 24% of pts (p=0.002), respectively in E and A cohort. At time of analysis E is ongoing in 3 pts (4%) and A in 9 pts (20%) (p=0.008). Third-line therapy (3L) was administrated in 62% of pts after E and in 33% after A (p=0.003). The most common 3L after E is A (48%) and vice versa the most common after A is E (71%). Median PFS of 3L after E is 9.1 mo (12.1 mo for A and 8 mo when 3L is not A (p=0.17)). Median PFS of 3L after A is 7.8 mo (95%CI 4-12). Conclusions: No statistically significant difference for PFS and OS were observed. Nevertheless, A showed more PR than E, while more pts received 3L after E. A remains very active in 3L. [Table: see text]
Patient's self-reported adherence to capecitabine on XELOX as adjuvant therapy for colorectal cancer.
Authors: Kazuyoshi Kawakami, Takashi Yokokawa, Kazuo Sugita, Akane Hagino, Kenichi Suzuki, Sayaka Oniyama, Satoshi Kohdo, Yohiaki Machida, Mitsukuni Suenaga, Nobuyuki Mizunuma, Tohiharu Yamaguchi, Toshihiro Hama
Journal: Journal of Clinical Oncology (2015)

690 Background: Capecitabine plus oxaliplatin (XELOX) has been established as adjuvant therapy for stage II/III colon cancer. Adherence to capecitabine is particularly important with XELOX to maintain appropriate curative effect. In this study, we monitored the adherence to capecitabine during adjuvant treatment with XELOX, and investigated the candidate factors that might decrease the adherence. Methods: The study included 139 consecutive patients who received XELOX treatment as adjuvant therapy for colorectal cancer between November 2011 and March 2014. Adherence to capecitabine was checked by pharmacists using a patient-reported treatment diary at a pharmaceutical outpatient clinic. Adherence rate was defined as the number of which a patient took capecitabine between d1 evening and d15 morning per 28 in each treatment cycle. The relative dose intensities and the deteriorating factors of adherence to capecitabine were retrospectively surveyed from electronic patient records. Results: 70 male and 69 female patients received adjuvant XELOX. Median adherence rate was 95.4% (n=139) in the first cycle of XELOX treatment, which gradually rose to 98.3% (n=121) in the eighth cycle. The median relative dose intensity of capecitabine was 76.7%. The main factors contributing to decreased adherence to capecitabine were diarrhea (34.7%) and nausea/vomiting (20.2%), peripheral neuropathy (10.7%). Conclusions: In this study, patient-reported adherence to capecitabine on XELOX treatment in clinical practice was highly maintained during all treatment cycles, and poor-adherence appeared to correlate with gastrointestinal events such as diarrhea, nausea, or vomiting. Our results suggest that assessment for compliance along with management of adverse events is needed to maintain treatment effect in clinical practice.
Statins reduce acute graft-versus-host disease in patients with acute leukemia undergoing allogeneic transplantation
Authors: M. Hamadani, F. T. Awan, P. Elder, S. M. Devine
Journal: Journal of Clinical Oncology (2008)

7040 Background: In animal models statins demonstrate protective effects against acute graft-versus-host disease (GVHD), while preserving graft-versus-leukemia (GVL) activity, through Th-2 polarization in donor T-cells and down regulation of co-stimulatory molecules and MHC-II expression in recipient antigen presenting cells (Zeiser R. Blood 2007;110:4588–98). However the effects of statins on acute GVHD following human allogeneic stem cell transplantation (SCT) have not been studied. Methods: 67 consecutive patients (pts) with acute leukemia underwent T-cell replete allogeneic SCT between 6/2002 and 10/2006 at our institution. Pts taking statins at ≥40mg/day for at least 1 month before and 3 months after allogeneic SCT (n=10) were compared to those without statin use (n=57). Results: The median age was 43 years (range 20–73yrs). Diagnosis included acute myeloid leukemia (AML) (n=49) and acute lymphoblastic leukemia (ALL) (n=18). The two groups were matched for baseline characteristics including age, diagnosis, stem cell source, donor type, degree of HLA-compatibility, GVHD prophylaxis, conditioning regimen and disease-risk category (p-value > 0.05). Rate of grade II-IV acute GVHD was 10% (n=1) in the statin group compared to 40% (n=23) in the no-statin group. This difference was however not statistically significant (p-value=0.08). 56 pts were evaluable for chronic GVHD. No difference in the incidence of chronic GVHD was seen in pts using statins (55%) compared to those in no-statin group (57%) (p-value=0.9). No pts in either group experienced engraftment failure. On subgroup analysis of pts with AML (n=49), significantly reduced incidence of grade II-IV acute GVHD was seen in statin group (0%) compared to 43% (n=18) in the no-statin group (p-value=0.02). Rates of chronic GVHD were 43% and 58% in similar order (p-value=0.68). KM estimates of progression free survival (PFS) at 3years in AML patients with or without statin use were 54% and 28% respectively (p-value=0.17) respectively. This non significant trend of improved PFS indicates that the GVL effect is preserved in transplant pts using statins. Conclusion: This study hints at the potential of statins in reducing acute GVHD while preserving GVL effect in AML pts undergoing allogeneic SCT. No significant financial relationships to disclose.