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Second-Line Palliative Chemotherapy in Advanced Gall Bladder Cancer, CAP-IRI: Safe and Effective Option

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Abstract

Introduction

Gall bladder cancer (GBC) has high prevalence in the Indo-Gangetic belt in India. While the first-line chemotherapy (CT1) has been established as gemcitabine–platinum doublet in advanced GBC, there is no standard recommendation or guidelines regarding feasibility of second-line therapy.

Methods

We performed a retrospective analysis of all patients who received second-line of chemotherapy (CT2) at our institution from July 2012 to December 2014. Patient records were examined for efficacy and toxicity of administered CT2, along with response rates (RR) and survival. Potential prognostic factors were also evaluated.

Results

Eighty-seven patients received CT2 in the predefined period. Ninety-nine percent of patients had received a gemcitabine-based regimen as CT1 with a median progression-free survival (PFS) of 5 months before CT2. 51.7 % patients had undergone surgery prior with 5.7 % patients having received radiotherapy previously. Prior to beginning CT2, PS was 0/1 in 67.8 % patients, albumin was >4 g% in 40.2 % and CA 19.9 was raised in a majority (66.7 %) patients, respectively. As per institution protocol, a majority of patients (89.6 %) were administered CAP-IRI regimen. Overall RR and disease control rates (DCR) were 21.8 % and 41.3 %, respectively. Median progression-free survival (PFS) and overall survival (OS) were 6 and 8 months, with no significant differences between CAP-IRI and other regimens. Adverse effects were tolerable, with dose reduced upfront in 23 % patients and 11.5 % patients during subsequent cycles of CT. ECOG Performance Status (PS) of 0/1 was a significant prognostic variable for OS on multivariate analysis (p = 0.003).

Conclusion

CAP-IRI is a well-tolerated second-line chemotherapeutic regimen in patients with advanced GBC. Careful selection of patients is required when administering second-line chemotherapy to advanced GBC patients, with particular emphasis on ECOG PS.

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Authors and Affiliations

  1. Department of Medical Oncology, TMH, E. Borges Road, Parel, Mumbai, 400012, India

    Anant Ramaswamy, Vikas Ostwal, Nikhil Pande, Arvind Sahu, Sunny Jandyal & Sudeep Gupta

  2. Department of Pathology, TMH, Mumbai, 400012, India

    Mukta Ramadwar

  3. Department of Interventional Radiology, TMH, Mumbai, 400012, India

    Nitin Shetty

  4. Department of Surgical Oncology, TMH, Mumbai, 400012, India

    Shraddha Patkar & Mahesh Goel

Authors
  1. Anant Ramaswamy
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  2. Vikas Ostwal
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  3. Nikhil Pande
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  4. Arvind Sahu
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  5. Sunny Jandyal
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  6. Mukta Ramadwar
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Correspondence to Vikas Ostwal.

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Key Message:

In gall bladder cancers, with the use of second-line chemotherapy like CAP-IRI, the ORR, DCR, Median PFS and OS were 21.8 %, 41.3 %, 6 months and 8 months respectively. Adverse effects were tolerable, with dose reduction upfront and in subsequent cycles were 23 and 11.5 % patients respectively. ECOG PS of 0/1 was a significant prognostic variable for OS on multivariate analysis (p = 0.003).

This is a first study which concentrates only on gall bladder cancers and here we introduce CAP-IRI, a safe and effective option in second line with selection of patients based on ECOG PS. As we see approximately 600 gall bladder cancers per year, it can form a base for considering second-line chemotherapy in patients with good ECOG PS as well as a future randomized Phase 3 trial comparing this regimen with best supportive care.

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Ramaswamy, A., Ostwal, V., Pande, N. et al. Second-Line Palliative Chemotherapy in Advanced Gall Bladder Cancer, CAP-IRI: Safe and Effective Option. J Gastrointest Canc 47, 305–312 (2016). https://doi.org/10.1007/s12029-016-9828-2

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  • DOI: https://doi.org/10.1007/s12029-016-9828-2

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