ORCID Profile
0000-0001-7571-2385
Current Organisation
Vanderbilt University Medical Center
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Publisher: American Society of Clinical Oncology (ASCO)
Date: 10-04-2023
DOI: 10.1200/JCO.22.01134
Abstract: This randomized, open-label trial compared the efficacy and safety of adjuvant nab-paclitaxel + gemcitabine with those of gemcitabine for resected pancreatic ductal adenocarcinoma (ClinicalTrials.gov identifier: NCT01964430 ). We assigned 866 treatment-naive patients with pancreatic ductal adenocarcinoma to nab-paclitaxel (125 mg/m 2 ) + gemcitabine (1,000 mg/m 2 ) or gemcitabine alone to one 30-40 infusion on days 1, 8, and 15 of six 28-day cycles. The primary end point was independently assessed disease-free survival (DFS). Additional end points included investigator-assessed DFS, overall survival (OS), and safety. Two hundred eighty-seven of 432 patients and 310 of 434 patients completed nab-paclitaxel + gemcitabine and gemcitabine treatment, respectively. At primary data cutoff (December 31, 2018 median follow-up, 38.5 [interquartile range [IQR], 33.8-43 months), the median independently assessed DFS was 19.4 ( nab-paclitaxel + gemcitabine) versus 18.8 months (gemcitabine hazard ratio [HR], 0.88 95% CI, 0.729 to 1.063 P = .18). The median investigator-assessed DFS was 16.6 (IQR, 8.4-47.0) and 13.7 (IQR, 8.3-44.1) months, respectively (HR, 0.82 95% CI, 0.694 to 0.965 P = .02). The median OS (427 events 68% mature) was 40.5 (IQR, 20.7 to not reached) and 36.2 (IQR, 17.7-53.3) months, respectively (HR, 0.82 95% CI, 0.680 to 0.996 P = .045). At a 16-month follow-up (cutoff, April 3, 2020 median follow-up, 51.4 months [IQR, 47.0-57.0]), the median OS (511 events 81% mature) was 41.8 ( nab-paclitaxel + gemcitabine) versus 37.7 months (gemcitabine HR, 0.82 95% CI, 0.687 to 0.973 P = .0232). At the 5-year follow-up (cutoff, April 9, 2021 median follow-up, 63.2 months [IQR, 60.1-68.7]), the median OS (555 events 88% mature) was 41.8 versus 37.7 months, respectively (HR, 0.80 95% CI, 0.678 to 0.947 P = .0091). Eighty-six percent ( nab-paclitaxel + gemcitabine) and 68% (gemcitabine) of patients experienced grade ≥ 3 treatment-emergent adverse events. Two patients per study arm died of treatment-emergent adverse events. The primary end point (independently assessed DFS) was not met despite favorable OS seen with nab-paclitaxel + gemcitabine.
Publisher: BMJ
Date: 20-10-2023
Publisher: BMJ
Date: 20-10-2023
Publisher: American Society of Clinical Oncology (ASCO)
Date: 10-03-2021
DOI: 10.1200/JCO.21.02538
Abstract: To develop recommendations for adjuvant therapy for patients with resected stage II colon cancer. ASCO convened an Expert Panel to conduct a systematic review of relevant studies and develop recommendations for clinical practice. Twenty-one observational studies and six randomized controlled trials met the systematic review inclusion criteria. Adjuvant chemotherapy (ACT) is not routinely recommended for patients with stage II colon cancer who are not in a high-risk subgroup. Patients with T4 tumors are at higher risk of recurrence and should be offered ACT, whereas patients with other high-risk factors, including s ling of fewer than 12 lymph nodes in the surgical specimen, perineural or lymphovascular invasion, poorly or undifferentiated tumor grade, intestinal obstruction, tumor perforation, or grade BD3 tumor budding, may be offered ACT. The addition of oxaliplatin to fluoropyrimidine-based ACT is not routinely recommended, but may be offered as a result of shared decision making. Patients with mismatch repair deficiency/microsatellite instability tumors should not be routinely offered ACT if the combination of mismatch repair deficiency/microsatellite instability and high-risk factors results in a decision to offer ACT, oxaliplatin-containing chemotherapy is recommended. Duration of oxaliplatin-containing chemotherapy is also addressed, with recommendations for 3 or 6 months of treatment with capecitabine and oxaliplatin or fluorouracil, leucovorin, and oxaliplatin, with decision making informed by key evidence of 5-year disease-free survival in each treatment subgroup and the rate of adverse events, including peripheral neuropathy. Additional information is available at astrointestinal-cancer-guidelines .
Location: United States of America
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