Nab-paclitaxel plus gemcitabine may expand advanced cholangiocarcinoma armamentarium
medwireNews: Nanoparticle albumin-bound (nab)-paclitaxel given alongside gemcitabine may offer an alternative to existing regimens for patients with untreated advanced or metastatic cholangiocarcinoma, phase II study findings suggest.
The combination’s 6-month progression-free survival (PFS) rate of 61% did not meet the primary endpoint threshold of 70% required to demonstrate improved efficacy compared with historical results, report Vaibhav Sahai, from the University of Michigan in Ann Arbor, USA, and colleagues.
Nevertheless, the researchers say the median PFS value of 7.7 months for nab-paclitaxel plus gemcitabine is comparable to the median PFS values reported for phase II trials of gemcitabine plus oxaliplatin and gemcitabine plus capecitabine, at 6.1 months and 6.2 months, respectively.
Similarly, the 74 patients given first-line nab-paclitaxel 125 mg/m2 followed by gemcitabine 1000 mg/m2 on days 1, 8 and 15 of a 28-day cycle in the current study had a median overall survival of 12.4 months. The reported durations for gemcitabine plus oxaliplatin, and gemcitabine plus capecitabine are 12.4 months and 12.7 months, respectively.
The overall response rate with nab-paclitaxel plus gemcitabine was 30% and the disease control rate was 66%, with a median time to progression of 7.7 months, the researchers write in JAMA Oncology.
Nab-paclitaxel plus gemcitabine had an “acceptable safety profile”, with “no new unexpected toxicities”, they continue.
Overall, 82% of study participants experienced a grade 3 or more severe treatment-related adverse event, most commonly the haematological side effects of neutropenia (43%), thrombocytopenia (16%) and anaemia (15%). Fatigue (14%) and elevated alkaline phosphatase (10%) were the most common nonhaematological events at grade 3 and above.
“On the basis of the adverse event profile, [nab-paclitaxel] plus gemcitabine treatment may be considered for patients who are not otherwise considered candidates for cisplatin-based therapy, specifically those with renal dysfunction”, Sahai et al say.
They conclude: “The addition of taxanes to gemcitabine […] appears to be effective for treatment of [cholangiocarcinoma] and is now being evaluated in combination with gemcitabine and cisplatin with encouraging preliminary data.”
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