The triplet regimen of nab-paclitaxel plus gemcitabine plus cisplatin (GCN) did not improve the health outcomes in untreated patients with advanced biliary tract cancer (BTC), the first-ever phase 3 trial in this population demonstrated.
A phase 2 study displayed encouraging anti-tumour activity of GCN in patients with advanced BTC, with a reported median overall survival (OS) of 19.2 months . Following these results, Prof. Rachna Shroff (University of Arizona Cancer Center, AZ, USA) and co-investigators designed the first phase 3 trial in patients with untreated, advanced cholangiocarcinoma or gallbladder cancer (n=441) . Patients were randomised 2:1 to gemcitabine, 800 mg/m2, plus cisplatin, 25 mg/m2, and nab-paclitaxel, 100 mg/m2, intravenous administration at days 1 and 8 of a 21-day cycle, or to standard-of-care gemcitabine plus cisplatin. The OS was the primary endpoint of the study.
Patients receiving the triplet regimen did not show a significantly improved OS compared with patients receiving the standard-of-care (median OS 14.0 months vs 12.7 months; P=0.65, see Figure). Progression-free survival data of the 2 study groups confirmed this result (8.2 months vs 6.4 months; P=0.43). Prof. Shroff added that grade 3 or 4 haematologic toxicities were more common in the GCN arm than in the control arm: anaemia (33% vs 22%); neutropaenia (37% vs 28%); thrombocytopenia (20% vs 15%); leukopenia (25% vs 10%). Discontinuation due to toxicity was 24% versus 19% (P=0.26) with GCN versus the standard-of-care.
Figure: No overall survival benefit for triplet regimen versus doublet regimen 
The first randomised phase 3 trial in patients with these rare types of cancer did not deliver evidence that supports the addition of nab-paclitaxel to gemcitabine and cisplatin. The experimental arm showed higher haematologic toxicity with no improved OS. Currently, the standard arm should be gemcitabine/cisplatin plus immunotherapy.
- Shroff RT, et al. JAMA Oncology. 2019;5(6):824–830.
- Shroff RT, et al. SWOG 1815: A phase III randomized trial of gemcitabine, cisplatin, and nab-paclitaxel versus gemcitabine and cisplatin in newly diagnosed, advanced biliary tract cancers. Late-breaking abstract 490, ASCO GI 2023, 19–21 January, San Francisco, CA, USA.
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Table of Contents: ASCO GI 2023
Letter from the Editor
ASCO GI 2023 Highlights Podcast
Oesophageal and Gastric Cancer
Zolbetuximab plus mFOLFOX6 successful in CLDN18.2-positive subgroup of gastric cancer
Regorafenib offers survival benefit for patients with pre-treated gastric cancer
Radiotherapy or not in locally advanced oesophageal or junctional cancer?
Neoadjuvant immunotherapy is safe and efficacious in a phase 2 gastric cancer trial
S-1 adjuvant chemotherapy: 4 or 8 courses in stage 2 gastric cancer?
LATG/LAPG demonstrates excellent long-term efficacy in stage 1 gastric cancer
3-year follow-up data confirms benefits of nivolumab plus chemotherapy
Long-term results for nivolumab plus chemotherapy and nivolumab plus ipilimumab in oesophageal cancer
Promising phase 2 results for HER-Vaxx in gastric cancer
Anal and Colorectal Cancer
IMbrave 151 missed primary endpoint in advanced BTC
Combination botensilimab plus balstilimab demonstrates promising activity in heavily pre-treated MSS CRC
Mutation-based selection to identify patients suitable for panitumumab treatment
Fucoidan associated with quality-of-life benefits in patients with rectal cancer receiving CCRT
ctDNA appears useful in monitoring patients with anal cancer undergoing CRT
SUNLIGHT trial meets primary endpoint in refractory metastatic CRC
Does cell-free DNA influence MRD testing in post-operative colon cancer?
OPERA: surgery may be avoided with adequate therapy in rectal cancer
Can we improve total neoadjuvant therapy for rectal cancer?
Palliative radiation therapy improves hepatic pain in HCC and liver metastasis
Improved survival following postoperative sorafenib plus TACE in HCC
Quality-of-life benefits for tislelizumab in uHCC
Stereotactic body radiation therapy beneficial for patients with locally advanced HCC
SWOG 1815, first-ever phase 3 trial in BTC, fails
Acceptable safety profile and encouraging efficacy of nanvuranlat in BTC
First-line NALIRIFOX superior to standard treatment in mPDAC
Novel approach delivers quality-of-life benefits for patients with pancreatic cancer
Immune-mediated diseases tied to risk of cancer
Zanidatamab provides ORR in HER2+ biliary tract cancer