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Gemcitabine, Cisplatin, and Nab-Paclitaxel as a First-Line Therapy for Advanced Biliary Tract Cancers

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Abstract

Introduction

Locally advanced, inoperable, or metastatic gallbladder cancers (GBC) are treated with either gemcitabine-platinum combinations or gemcitabine alone based on physician discretion. However, the combination of gemcitabine, cisplatin, and nab-paclitaxel (GCNP) has shown increased response rates and prolonged survival in a phase II trial of biliary tract patients.

Materials and Methods

Consecutive series of patients diagnosed with locally advanced (liver infiltration > 5 cm, large nodes at porta, abutting duodenum), inoperable, and metastatic biliary tract patients between January 2018 and August 2022 were evaluated for first-line chemotherapy GCNP, in the multidisciplinary joint clinic (MDJC). The primary endpoint was ORR, and the major secondary endpoint was event-free survival (EFS).

Results

A total of 142 patients received GCNP during the specified time period. The median age of the cohort was 52 years (range: 21–79), the majority were females (61.3%), and the majority were GB (81.7%). Response rates were available in 137 patients. Complete response, partial response, and stable disease were seen in 9 (6.3%), 87 (61.3%), and 24 (16.9%), respectively, for an ORR of 67.6% and a clinical benefit rate of 84.5%. The median EFS was 9.92 (95% CI, 7.69–12.14) months. Of the 52 patients in whom GCNP was given with NACT intent for locally advanced GBC, 17 patients underwent surgery (34%).

Conclusion

Our study indicates that GCNP leads to improved response rates, increased chances of resectability, and possibly better survival in patients with GBC.

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Data Availability

The data is available on a reasonal request after the appropriate approvals. 

Abbreviations

BSC:

Best supportive care

CBR:

Clinical benefit rates

CI:

Confidence interval

CR:

Complete response

DFS:

Disease-free survival

EFS:

Event-free survival

GBC:

Gallbladder cancer

GCNP:

Gemcitabine, cisplatin, and nab-paclitaxel

MDJC:

Multidisciplinary joint clinic

NACT:

Neoadjuvant chemotherapy

NR:

Not reached

ORR:

Overall response rate

OS:

Overall survival

PR:

Partial response

PFS:

Progression‑free survival

RR:

Response rate

SD:

Stable disease

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Authors and Affiliations

  1. Department of Medical Oncology, Tata Memorial Hospital, Homi Bhabha National Institute (HBNI), Dr. E Borges Road, Parel, Mumbai, 400 012, India

    Sandeep Gedela, Pritesh Munot, Arvind Vaidyanathan, Ritam Joarder, Deepali Chaugule, Manali Parulekar, Divya Vadodaria, Sarika Mandavkar, Anant Ramaswamy, Prabhat Bhargava, Sujay Srinivas & Vikas Ostwal

  2. Tata Memorial Hospital, Homi Bhabha National Institute (HBNI), Dr. E Borges Road, Parel, Mumbai, 400 012, India

    Chaitali Nashikkar & Aayushi Ghadi

  3. Gastrointestinal & HPB Surgery, Department of Surgical Oncology, Tata Memorial Hospital, Homi Bhabha National Institute (HBNI), Dr. E Borges Road, Parel, Mumbai, 400 012, India

    Mahesh Goel

  4. Department of Surgical Oncology, GI & HPB Services, Tata Memorial Hospital, Homi Bhabha National Institute (HBNI), Dr. E Borges Road, Parel, Mumbai, 400 012, India

    Shraddha Patkar

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  1. Sandeep Gedela
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Contributions

All authors contributed to the study’s conception and design. Material preparation, data collection, and analysis were performed by Dr Sandip Gadela, Dr Pritesh Munot, Dr Arvind Vaidyanathan, Dr Ritam Joradar, Ms Deepali Chaugule, Ms Manali Parulekar, Dr. Chaitali Nashikkar, Ms Aayushi Ghadi, Ms Divya Vadodaria, Dr Mahesh Goel, Dr Shraddha Patkar, and Ms. Sarika Mandavkar. The first draft of the manuscript was written by Dr. Anant Ramaswamy, Dr. Prabhat Bhargava, Dr. Sujay Srinivas, and Dr. Vikas Ostwal, and all authors commented on previous versions of the manuscript. All authors read and approved the final manuscript.

Corresponding author

Correspondence to Vikas Ostwal.

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Gedela, S., Munot, P., Vaidyanathan, A. et al. Gemcitabine, Cisplatin, and Nab-Paclitaxel as a First-Line Therapy for Advanced Biliary Tract Cancers. J Gastrointest Canc (2023). https://doi.org/10.1007/s12029-023-00946-z

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