Abstract 109P
Background
Adjuvant CAPOX (capecitabine plus oxaliplatin) provided significant disease-free survival (DFS) benefit in patients with high-risk stage Ⅱor stage Ⅲ colorectal cancer (CRC), which might translate into long-term overall survival (OS). However, the standard triweekly CAPOX has recently raised some concerns onits hematological toxicity such as thrombocytopenia, which results in discontinuation ofadjuvant courses in a majority of patients. The regimen of modified biweekly CAPOX was observed to be generally well-tolerated in previous studies.
Methods
We conducted a prospective, phase II study to investigate the efficacy and safety between these two adjuvant chemotherapy models. Patients were randomized (1:1) to receive capecitabine 1000mg/m2 BID D1-D14 with oxaliplatin 130mg/m2 IV D1, Q21 days(standard triweekly arm) or capecitabine 1000mg/m2 BID D1-D10 with oxaliplatin 85mg/m2 IV D1, Q14 days (modifiedbiweeklyarm) as adjuvant therapy. Patients with T3N1M0 disease would receive 3 months of adjuvant chemotherapy while patients who had T4 or N2 disease would receive 6 months of adjuvant chemotherapy. The primary endpoint was DFSwhile safety and OS were secondary endpoints.
Results
Since the enrollment of the first patient on June 28, 2018, 85 patients have been enrolled, 59 of whom have completely completed adjuvant therapy, 20 patients are still in treatment, and 6 patients terminated the treatment due to personal reasons, adverse reactions intolerant or postoperative complications such as intestinal adhesion. Of the 59 patients who completed adjuvant therapy, 29 received the triweekly regimen and 30 received the biweekly regimen, respectively. Leukopenia was 43% in the biweekly group and 58% in the triweekly group. Thrombocytopenia was 33% at biweekly group, 51% at triweekly group. Peripheral neurotoxicity was 46% at biweekly group, and 75% at triweekly group. Table: 109P
Adverse events | Grade | Case No. | |
Biweekly XELOX | Triweekly XELOX | ||
WBC | I | 9 | 6 |
II | 3 43% | 10 58% | |
III | 1 | 1 | |
PLT | I | 4 | 7 |
II | 3 33% | 6 51% | |
III | 3 | 2 | |
Hb | I | 9. 36% | 5 20% |
II | 2 | 1 | |
Liver function injury | I | 2. 16% | 5 31% |
II | 3 | 4 | |
Peripheral neurotoxicity | I | 7 | 10 |
II | 3 46% | 5 75% | |
III | 4 | 7 |
Conclusions
Blood toxicity was significantly reduced in the biweekly treatment group, as were liver function injury and neurotoxicity.DFS and OS are not available for the time being due to immature data.
Clinical trial identification
Editorial acknowledgement
Legal entity responsible for the study
The authors.
Funding
Has not received any funding.
Disclosure
All authors have declared no conflicts of interest.
Resources from the same session
184P - Development and external validation of a nomogram to predict recurrence-free survival after R0 resection for stage II/III gastric adenocarcinoma: An international multicenter study
Presenter: Bin-Bin Xu
Session: e-Poster Display Session
185P - Effect of sarcopenia on short- and long-term outcomes of patients with gastric neuroendocrine tumour after radical surgery: Results from a large, two-institutional series
Presenter: Ling-Qian Wang
Session: e-Poster Display Session
186P - Characterization of the gastroenteropancreatic neuroendocrine tumour patient journey
Presenter: George Fisher Jr
Session: e-Poster Display Session
187P - More is not always better: A multicenter study in lymphadenectomy during gastrectomy for gastric neuroendocrine carcinoma
Presenter: Qi-Yue Chen
Session: e-Poster Display Session
188P - The impact of sarcopenia on chemotherapy toxicity and survival rate among pancreatic cancer patients who underwent chemotherapy: A systematic review and meta-analysis
Presenter: Billy Susanto
Session: e-Poster Display Session
189P - Prognostic value of inflammation-based score for patients treated with FOLFIRINOX (FFX) or gemcitabine plus nab-paclitaxel (GnP)
Presenter: Takahiro Yamamura
Session: e-Poster Display Session
190P - Outcomes from the Asian region of the phase III APACT trial of adjuvant nab-paclitaxel plus gemcitabine (nab-P/G) vs gemcitabine (G) alone for patients (pts) with resected pancreatic cancer (PC)
Presenter: Joon Oh Park
Session: e-Poster Display Session
191P - First-line liposomal irinotecan + 5 fluorouracil/leucovorin + oxaliplatin in patients with pancreatic ductal adenocarcinoma: Results from a phase I/II study
Presenter: Andrew Dean
Session: e-Poster Display Session
192P - A multicenter crossover analysis of first and second-line FOLFIRINOX or gemcitabine plus nab-paclitaxel administered to pancreatic cancer patients: Results from the NAPOLEON study
Presenter: Kenta Nio
Session: e-Poster Display Session
193P - First-line liposomal irinotecan + 5 fluorouracil/leucovorin + oxaliplatin in patients with pancreatic ductal adenocarcinoma: Exploratory survival analyses by change in post treatment CA 19-9
Presenter: Andrew Dean
Session: e-Poster Display Session