NAB-PACLITAXEL as third-line therapy after failure of gemcitabine and 5-FU based combinations in advanced gall bladder cancer patients

Background

There is no standard third-line chemotherapy after progression on two-lines of therapy including gemcitabine/platinum and FOLFOX-4 based chemotherapy regimens in metastatic gall bladder cancer patients. So this study was undertaken to assess the efficacy and safety of single agent nab-paclitaxel in this setting.

Methods

The was a single arm prospective study, patients with performance status ≤2, who progressed on two-lines of therapy, were enrolled from May 2012 to December 2015. Single agent nab-paclitaxel (dose 125mg/m²) was administered on Day 1, 8 and 15 in a cycle of 28 days and i.e. until progression or unacceptable toxicity. Response evaluation was done after 2 cycles of chemotherapy.

Results

A total of 24 patients were enrolled in this study. The median age of patients was 60 years (31–71 years), of which 10 (41.66%) were males and 14 (58.33%) were females. The median number of cycles could be given were 3.07 (0.5 – 9.6). 13 patients (54.16%) could be given more than 3 cycles of chemotherapy and only 3 patients (12.5%) in this study received more than 6 cycles of chemotherapy. Disease control rate was seen in 16 (66.66%) patients, with complete response in none, partial response in 9 (37.5%), stable disease in 7 (29.16%) and progressive disease in 8 (33.33%) patients. The median progression free survival was 2.86 months (95% CI: 2.31-3.41); The main Grade 3/4 side effects seen were hematological in 33.33% (n = 8). 7 patients (29.16%) had Grade 1/2 peripheral neuropathy.

Conclusions

Nab-paclitaxel is an effective and well-tolerated agent as a third-line option in metastatic gall bladder cancer patients. Further studies are required, especially in the Indian subcontinent.

Clinical trial identification

None

Legal entity responsible for the study

Rajiv Gandhi Cancer Institute

Funding

Rajiv Gandhi Cancer Institute

Disclosure

All authors have declared no conflicts of interest.