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https://www.readbyqxmd.com/read/27864694/the-effect-on-surgical-complications-of-bevacizumab-added-to-neoadjuvant-chemotherapy-for-breast-cancer-nrg-oncology-nsabp-protocol-b-40
#1
Harry D Bear, Gong Tang, Priya Rastogi, Charles E Geyer, Christine K Zoon, Kelley M Kidwell, André Robidoux, Luis Baez-Diaz, Adam M Brufsky, Rita S Mehta, Louis Fehrenbacher, James A Young, Francis M Senecal, Rakesh Gaur, Richard G Margolese, Paul T Adams, Howard M Gross, Joseph P Costantino, Soonmyung Paik, Sandra M Swain, Eleftherios P Mamounas, Norman Wolmark
BACKGROUND: NRG Oncology/NSABP trial B-40 tested the impact of adding bevacizumab (bev) to neoadjuvant chemotherapy for operable breast cancer. Secondary endpoints included rates of surgical complications after surgery in patients who did or did not receive bev. METHODS: A total of 1206 women with HER2-negative operable breast cancer were randomly assigned to receive one of three different docetaxel-plus-anthracycline-based regimens, without or with bev (15 mg/kg every 3 weeks) for the first 6 of 8 cycles and for 10 doses postoperatively...
November 18, 2016: Annals of Surgical Oncology
https://www.readbyqxmd.com/read/27812689/association-of-polymorphisms-in-fcgr2a-and-fcgr3a-with-degree-of-trastuzumab-benefit-in-the-adjuvant-treatment-of-erbb2-her2-positive-breast-cancer-analysis-of-the-nsabp-b-31-trial
#2
Patrick G Gavin, Nan Song, S Rim Kim, Corey Lipchik, Nicole L Johnson, Hanna Bandos, Melanie Finnigan, Priya Rastogi, Louis Fehrenbacher, Eleftherios P Mamounas, Sandra M Swain, D Lawrence Wickerham, Charles E Geyer, Jong-Hyeon Jeong, Joseph P Costantino, Norman Wolmark, Soonmyung Paik, Kay L Pogue-Geile
Importance: Preclinical models and studies in the metastatic and neoadjuvant settings suggest that single nucleotide polymorphisms in FCGR3A and FCGR2A may be associated with differential response to trastuzumab in the treatment of ERBB2/HER2-positive breast cancer, by modulating antibody-dependent cell-mediated cytotoxic effects. Objective: To evaluate the effect of FCGR2A and FCGR3A polymorphisms on trastuzumab efficacy in the adjuvant treatment of ERBB2/HER2-positive breast cancer...
November 3, 2016: JAMA Oncology
https://www.readbyqxmd.com/read/27730423/assessment-of-pathologic-response-and-long-term-outcome-in-locally-advanced-breast-cancers-after-neoadjuvant-chemotherapy-comparison-of-pathologic-classification-systems
#3
Misun Choi, Yeon Hee Park, Jin Seok Ahn, Young-Hyuck Im, Seok Jin Nam, Soo Youn Cho, Eun Yoon Cho
PURPOSE: Several pathologic classification systems have been developed to evaluate tumor response after neoadjuvant chemotherapy (NAC) for breast cancer. We aimed to compare pathologic classification systems and to investigate prognostic factors and risk stratification according to molecular subtype in relation to survival. METHODS: We retrospectively evaluated pathologic response after NAC in 485 breast cancer patients by applying the National Surgical Adjuvant Breast and Bowel Project B18 trial (NSABP-B18), Miller and Payne system, Chevallier's classification, Sataloff's classification, residual cancer burden (RCB), residual disease in breast and nodes (RDBN), and clinical-pathologic stage + estrogen receptor status and grade staging system (CPS + EG)...
October 11, 2016: Breast Cancer Research and Treatment
https://www.readbyqxmd.com/read/27693116/epirubicin-with-cyclophosphamide-followed-by-docetaxel-with-trastuzumab-and-bevacizumab-as-neoadjuvant-therapy-for-her2-positive-locally-advanced-breast-cancer-or-as-adjuvant-therapy-for-her2-positive-pathologic-stage-iii-breast-cancer-a-phase-ii-trial-of-the
#4
John W Smith, Marc E Buyse, Priya Rastogi, Charles E Geyer, Samuel A Jacobs, Erica J Patocskai, André Robidoux, Alison K Conlin, Bilal Ansari, George P Keogh, Philip J Stella, Howard M Gross, Raymond S Lord, Jonathan A Polikoff, Celine Mauquoi, Eleftherios P Mamounas, Sandra M Swain, Norman Wolmark
BACKGROUND: The purpose of this study was to determine the cardiac safety and clinical activity of trastuzumab and bevacizumab with docetaxel after epirubicin with cyclophosphamide (EC) in patients with HER2-positive locally advanced breast cancer (LABC) or pathologic stage 3 breast cancer (PS3BC). PATIENTS AND METHODS: Patients received every 3 week treatment with 4 cycles of EC (90/600 mg/m(2)) followed by 4 cycles of docetaxel (100 mg/m(2)). Targeted therapy with standard-dose trastuzumab with bevacizumab 15 mg/kg was given for a total of 1 year...
July 28, 2016: Clinical Breast Cancer
https://www.readbyqxmd.com/read/27562475/quality-of-life-and-symptoms-in-long-term-survivors-of-colorectal-cancer-results-from-nsabp-protocol-lts-01
#5
Hiroko Kunitake, Marcia M Russell, Ping Zheng, Greg Yothers, Stephanie R Land, Laura Petersen, Louis Fehrenbacher, Jeffery K Giguere, D Lawrence Wickerham, Clifford Y Ko, Patricia A Ganz
PURPOSE: Little is known about health-related quality of life (HRQL) in long-term survivors (LTS) of colorectal cancer (CRC). METHODS: Long-term CRC survivors (≥5 years) treated in previous National Surgical Adjuvant Breast and Bowel Project trials were recruited from 60 sites. After obtaining consent, a telephone survey was administered, which included HRQL instruments to measure physical health (Instrumental Activities of Daily Living [IADL], SF-12 Physical Component Scale [PCS], SF-36 Vitality Scale), mental health (SF-12 Mental Component Scale [MCS], Life Orientation Test, and Impact of Cancer), and clinical symptoms (Fatigue Symptom Inventory [FSI], European Organization for Research and Treatment of Cancer Colorectal Module [EORTC-CR38], and Brief Pain Inventory)...
August 25, 2016: Journal of Cancer Survivorship: Research and Practice
https://www.readbyqxmd.com/read/27272823/once-daily-accelerated-partial-breast-irradiation-preliminary-results-with-helical-tomotherapy%C3%A2
#6
Ugo DE Paula, Rolando M D'Angelillo, Raffaele Barbara, Cristina Caruso, Sara Gomellini, Aurelia Caccavari, Leopoldo Costarelli, Paola Scavina, Maria Mauri, Elena Santini, Adriana Antonaci, Francesco Cavaliere, Massimo LA Pinta, Andrea Loreti, Lucio Fortunato
BACKGROUND: Accelerated partial breast irradiation (APBI) is becoming an option for patients with low-risk breast cancer. The current practice is 38.5 Gy in 10 fractions b.i.d. over 5 days. This fractionation has a higher bioequivalent dose compared to the standard schedule. We report on preliminary results of once-daily APBI in patients treated with TomoTherapy®. PATIENTS AND METHODS: Patients with unifocal-breast disease who underwent breast-conserving surgery were enrolled in the study...
June 2016: Anticancer Research
https://www.readbyqxmd.com/read/27270348/clinical-outcome-from-oxaliplatin-treatment-in-stage-ii-iii-colon-cancer-according-to-intrinsic-subtypes-secondary-analysis-of-nsabp-c-07-nrg-oncology-randomized-clinical-trial
#7
Nan Song, Katherine L Pogue-Geile, Patrick G Gavin, Greg Yothers, S Rim Kim, Nicole L Johnson, Corey Lipchik, Carmen J Allegra, Nicholas J Petrelli, Michael J O'Connell, Norman Wolmark, Soonmyung Paik
IMPORTANCE: Oxaliplatin added to fluorouracil plus leucovorin therapy for patients with colon cancer has been shown to provide significant but modest absolute benefit for disease-free survival. However, acute and chronic neurotoxic effects from this regimen underscore the need for markers that predict oxaliplatin benefit. OBJECTIVE: To test our hypothesis that molecular subtypes of colon cancer would be associated with differential prognosis and benefit from oxaliplatin added to fluorouracil plus leucovorin therapy...
September 1, 2016: JAMA Oncology
https://www.readbyqxmd.com/read/27047721/survival-in-patients-with-non-metastatic-breast-cancer-treated-with-adjuvant-trastuzumab-in-clinical-practice
#8
Christopher M Gallagher, Kenneth More, Anthony Masaquel, Tripthi Kamath, Annie Guerin, Raluca Ionescu-Ittu, Roy Nitulescu, Marjolaine Gauthier-Loiselle, Nicholas Sicignano, Elizabeth Butts, Eric Q Wu, Brian Barnett
PURPOSE: The NSABP Trial B-31 and NCCTG Trial N9831 (B-31/N9831 trials, Romond et al. in N Engl J Med 353:1673-84, 2005. doi:10.1056/NEJMoa052122; Perez et al. in J Clin Oncol 32:3744-52, 2014. doi:10.1200/JCO.2014.55.5730) established the efficacy of adjuvant trastuzumab for patients with HER2-positive early stage breast cancer. We aimed to estimate the overall survival (OS) and relapse-free survival (RFS) of HER2-positive non-metastatic breast cancer patients treated with adjuvant trastuzumab in a clinical practice setting in the United States...
2016: SpringerPlus
https://www.readbyqxmd.com/read/26709538/the-role-of-postmastectomy-radiotherapy-in-clinically-node-positive-stage-ii-iii-breast-cancer-patients-with-pathological-negative-nodes-after-neoadjuvant-chemotherapy-an-analysis-from-the-ncdb
#9
Jieqiong Liu, Kai Mao, Shuai Jiang, Wen Jiang, Kai Chen, Betty Y S Kim, Qiang Liu, Lisa K Jacobs
PURPOSE: The role of postmastectomy radiotherapy (PMRT) in clinically node-positive, stage II-III breast cancer patients with pathological negative nodes (ypN0) after neoadjuvant chemotherapy (NAC) remains controversial. METHODS: A total of 1560 clinically node-positive, stage II-III breast cancer patients treated with NAC and mastectomy who achieved ypN0 between 1998 and 2009 in the National Cancer Database were analyzed. The effects of PMRT on overall survival (OS) for the entire cohort and multiple subgroups were evaluated...
April 26, 2016: Oncotarget
https://www.readbyqxmd.com/read/26686960/patient-reported-outcomes-with-anastrozole-versus-tamoxifen-for-postmenopausal-patients-with-ductal-carcinoma-in-situ-treated-with-lumpectomy-plus-radiotherapy-nsabp-b-35-a-randomised-double-blind-phase-3-clinical-trial
#10
RANDOMIZED CONTROLLED TRIAL
Patricia A Ganz, Reena S Cecchini, Thomas B Julian, Richard G Margolese, Joseph P Costantino, Laura A Vallow, Kathy S Albain, Patrick W Whitworth, Mary E Cianfrocca, Adam M Brufsky, Howard M Gross, Gamini S Soori, Judith O Hopkins, Louis Fehrenbacher, Keren Sturtz, Timothy F Wozniak, Thomas E Seay, Eleftherios P Mamounas, Norman Wolmark
BACKGROUND: The NSABP B-35 trial compared 5 years of treatment with anastrozole versus tamoxifen for reducing subsequent occurrence of breast cancer in postmenopausal patients with ductal carcinoma in situ. This report assesses the effect of these drugs on quality of life and symptoms. METHODS: The study was done at 333 hospitals in North America. Postmenopausal women with hormone-positive ductal carcinoma in situ treated by lumpectomy with clear resection margins and whole breast irradiation were randomly assigned to receive either tamoxifen (20 mg/day) or anastrazole (1 mg/day) for 5 years, stratified by age (<60 years vs ≥60 years)...
February 27, 2016: Lancet
https://www.readbyqxmd.com/read/26686957/anastrozole-versus-tamoxifen-in-postmenopausal-women-with-ductal-carcinoma-in-situ-undergoing-lumpectomy-plus-radiotherapy-nsabp-b-35-a-randomised-double-blind-phase-3-clinical-trial
#11
RANDOMIZED CONTROLLED TRIAL
Richard G Margolese, Reena S Cecchini, Thomas B Julian, Patricia A Ganz, Joseph P Costantino, Laura A Vallow, Kathy S Albain, Patrick W Whitworth, Mary E Cianfrocca, Adam M Brufsky, Howard M Gross, Gamini S Soori, Judith O Hopkins, Louis Fehrenbacher, Keren Sturtz, Timothy F Wozniak, Thomas E Seay, Eleftherios P Mamounas, Norman Wolmark
BACKGROUND: Ductal carcinoma in situ is currently managed with excision, radiotherapy, and adjuvant hormone therapy, usually tamoxifen. We postulated that an aromatase inhibitor would be safer and more effective. We therefore undertook this trial to compare anastrozole versus tamoxifen in postmenopausal women with ductal carcinoma in situ undergoing lumpectomy plus radiotherapy. METHODS: The double-blind, randomised, phase 3 National Surgical Adjuvant Breast and Bowel Project (NSABP) B-35 trial was done in 333 participating NSABP centres in the USA and Canada...
February 27, 2016: Lancet
https://www.readbyqxmd.com/read/26617210/the-role-of-postmastectomy-radiation-therapy-in-patients-with-breast-cancer-responding-to-neoadjuvant-chemotherapy
#12
REVIEW
Jose G Bazan, Julia R White
When surgery is the first line of breast cancer treatment, numerous randomized clinical trials and meta-analyses have demonstrated that postmastectomy radiation therapy (PMRT) improves locoregional control and survival for many women with axillary lymph node-positive disease. In contrast, there are no randomized data regarding the use of PMRT in women who receive neoadjuvant chemotherapy (NAC) first followed by mastectomy. This has led to controversy regarding which patient with breast cancer will benefit from PMRT after NAC, particularly in women with clinically node-positive axillary disease that responds well and is down staged to pathologically negative disease at surgery (ypN0)...
January 2016: Seminars in Radiation Oncology
https://www.readbyqxmd.com/read/26615179/symptoms-and-qol-as-predictors-of-chemoprevention-adherence-in-nrg-oncology-nsabp-trial-p-1
#13
RANDOMIZED CONTROLLED TRIAL
Stephanie R Land, Farzana L Walcott, Qing Liu, D Lawrence Wickerham, Joseph P Costantino, Patricia A Ganz
BACKGROUND: Tamoxifen provides a 50% reduction in the incidence of breast cancer (BC) among high-risk women, yet many do not adhere to the five-year course of therapy. Using the prospective double-blind National Surgical Adjuvant Breast and Bowel Project P-1 study, we evaluated whether participant-reported outcomes were associated with drug adherence and whether baseline behavioral risk factors modified those associations. METHODS: P-1 participants were randomly assigned to placebo vs tamoxifen (20mg/day)...
April 2016: Journal of the National Cancer Institute
https://www.readbyqxmd.com/read/26545405/body-mass-index-at-diagnosis-and-breast-cancer-survival-prognosis-in-clinical-trial-populations-from-nrg-oncology-nsabp-b-30-b-31-b-34-and-b-38
#14
RANDOMIZED CONTROLLED TRIAL
Reena S Cecchini, Sandra M Swain, Joseph P Costantino, Priya Rastogi, Jong-Hyeon Jeong, Stewart J Anderson, Gong Tang, Charles E Geyer, Barry C Lembersky, Edward H Romond, Alexander H G Paterson, Norman Wolmark
BACKGROUND: Body mass index (BMI) has been associated with breast cancer outcomes. However, few studies used clinical trial settings where treatments and outcomes are consistently evaluated and documented. There are also limited data assessing how patient/disease characteristics and treatment may alter the BMI-breast cancer association. METHODS: We evaluated 15,538 breast cancer participants from four NSABP protocols. B-34 studied early-stage breast cancer patients (N = 3,311); B-30 and B-38 included node-positive breast cancer patients (N = 5,265 and 4,860); and B-31 studied node-positive and HER2-positive breast cancer patients (N = 2,102)...
January 2016: Cancer Epidemiology, Biomarkers & Prevention
https://www.readbyqxmd.com/read/26384802/postmastectomy-radiotherapy-after-neoadjuvant-chemotherapy-a-review-of-the-evidence
#15
REVIEW
Christina Hunter Chapman, Reshma Jagsi
Multiple randomized trials and their meta-analysis have demonstrated an overall survival benefit from postmastectomy radiotherapy (PMRT) in women with node-positive breast cancer. However, none of the patients treated in these trials received neoadjuvant chemotherapy, which is now an increasingly common approach. It is unclear how best to apply data from trials conducted in patients treated with adjuvant chemotherapy to this population. To illuminate these issues, this article first reviews the history of PMRT and the current indications for its use based on contemporary data...
September 2015: Oncology (Williston Park, NY)
https://www.readbyqxmd.com/read/26276354/octreotide-lar-and-tamoxifen-versus-tamoxifen-in-phase-iii-randomize-early-breast-cancer-trials-ncic-ctg-ma-14-and-nsabp-b-29
#16
RANDOMIZED CONTROLLED TRIAL
Judith-Anne W Chapman, Joseph P Costantino, Bin Dong, Richard G Margolese, Kathleen I Pritchard, Lois E Shepherd, Karen A Gelmon, Norman Wolmark, Michael N Pollak
NCIC CTG MA.14 and NSABP B-29 trials examined the addition of Octreotide LAR (OCT) to 5 years of tamoxifen (TAM). Gallbladder toxicity led to B-29 discontinuation of OCT, and MA.14 OCT administration shortened to 2 years. Median follow-up was 9.8 years for 667 MA.14 patients and 6.8 years for 893 B-29 patients. The primary endpoint was disease-free survival (DFS), defined as time from randomization to time of breast cancer recurrence; second primary cancer other than squamous or basal cell skin carcinoma, cervical carcinoma in situ, or lobular breast carcinoma in situ; or death...
September 2015: Breast Cancer Research and Treatment
https://www.readbyqxmd.com/read/26272770/neoadjuvant-plus-adjuvant-bevacizumab-in-early-breast-cancer-nsabp-b-40-nrg-oncology-secondary-outcomes-of-a-phase-3-randomised-controlled-trial
#17
RANDOMIZED CONTROLLED TRIAL
Harry D Bear, Gong Tang, Priya Rastogi, Charles E Geyer, Qing Liu, André Robidoux, Luis Baez-Diaz, Adam M Brufsky, Rita S Mehta, Louis Fehrenbacher, James A Young, Francis M Senecal, Rakesh Gaur, Richard G Margolese, Paul T Adams, Howard M Gross, Joseph P Costantino, Soonmyung Paik, Sandra M Swain, Eleftherios P Mamounas, Norman Wolmark
BACKGROUND: NSABP B-40 was a 3 × 2 factorial trial testing whether adding capecitabine or gemcitabine to docetaxel followed by doxorubicin plus cyclophosphamide neoadjuvant chemotherapy would improve outcomes in women with operable, HER2-negative breast cancer and whether adding neoadjuvant plus adjuvant bevacizumab to neoadjuvant chemotherapy regimens would also improve outcomes. As reported previously, addition of neoadjuvant bevacizumab increased the proportion of patients achieving a pathological complete response, which was the primary endpoint...
September 2015: Lancet Oncology
https://www.readbyqxmd.com/read/26128257/su-e-t-593-outcomes-and-toxicities-from-a-clinical-trial-of-apbi-using-mert-imrt-with-the-same-xmlc
#18
E Jimenez-Ortega, C Miguez-Sanchez, B Palma, A Ureba, H Miras, R Arrans, A R Barbeiro, J A Baeza, F Carrasco, A Leal Plaza
PURPOSE: We present the results from a clinical trial of accelerated partial breast irradiation (APBI), using mixed modulated photon and electron beams (MERT+IMRT) with the same photon multileaf collimator (xMLC). METHODS: Seven patients were enrolled in the first year of the APBI clinical trial. Patients were selected following the conditions included in the NSABP B-39/RTOG 0413 protocol. The targets and clinically relevant normal structures were contoured on the CT images following this protocol for APBI-EBRT...
June 2015: Medical Physics
https://www.readbyqxmd.com/read/26126970/phase-ii-randomized-clinical-trial-evaluating-neoadjuvant-chemotherapy-regimens-with-weekly-paclitaxel-or-eribulin-followed-by-doxorubicin-and-cyclophosphamide-in-women-with-locally-advanced-her2-negative-breast-cancer-nsabp-foundation-study-fb-9
#19
RANDOMIZED CONTROLLED TRIAL
Jame Abraham, André Robidoux, Antoinette R Tan, Steven Limentani, Keren Sturtz, Ibrahim Shalaby, Hope Alcorn, Marc E Buyse, Norman Wolmark, Samuel A Jacobs
Locally advanced breast cancer (LABC) is a good setting in which to monitor response to neoadjuvant chemotherapy, to downsize the tumor (which facilitates breast-conserving surgery), and to test newer agents in untreated patients. Eribulin (E) has shown activity in patients who have undergone previous taxane, anthracycline, and capecitabine treatment. We aimed to evaluate the neoadjuvant use of E followed by doxorubicin and cyclophosphamide (AC) in patients with HER2-negative LABC, using as a control a randomized group of women who received weekly paclitaxel (WP)...
July 2015: Breast Cancer Research and Treatment
https://www.readbyqxmd.com/read/25993172/locally-advanced-rectal-cancer-time-for-precision-therapeutics
#20
REVIEW
Martin R Weiser, Zhen Zhang, Deborah Schrag
The year 2015 marks the 30th anniversary of the publication of NSABP-R01, a landmark trial demonstrating the benefit of adding pelvic radiation to the treatment regimen for locally advanced rectal cancer with a resultant decrease in local recurrence from 25% to 16%. These results ushered in the era of multimodal therapy for rectal cancer, heralding modern treatment and changing the standard of care in the United States. We have seen many advances over the past 3 decades, including optimization of the administration and timing of radiation, widespread adoption of total mesorectal excision (TME), and the implementation of more effective systemic chemotherapy...
2015: American Society of Clinical Oncology Educational Book
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