Cancer of the gall bladder (CaGB) constitutes one of the ten commonest cancers in women in north India. Palliative chemotherapy is indicated for the advanced stage, inoperable patient in good performance status (PS). There is no standard-of-care regimen for this disease. We prospectively evaluated the efficacy & safety of GEMPLAT v/s CAPEOX chemotherapy in this cohort of patients.
Fifty chemo-naive, newly diagnosed patients (25 in each arm) of inoperable CA GB, in good PS (0, I, II) were included. Patients were randomised to receive either GEMPLAT or CAPOX. Primary end point was response rates (RR) & progression free survival (PFS); secondary end point: Overall survival (OS), toxicity & quality of life (QOL). Response assessment was done after every two cycles using by the RECIST 1.1 criteria. QOL was assessed every two cycles.
Thirty one females & 19 males, mean age of 45.7 years (range 32 to 69) were included. There were no CRs in either arm. Partial response (PR) & stable disease (SD) was seen in 6 (24%) & 8 (32%) patients, respectively, in GEMPLAT arm; and 2 (8%) and 5 (20%) achieved PR and SD, respectively in CAPEOX group. Overall response rate (ORR) was 24% & 8%, respectively, for GEMPLAT & CAPOX. The median OS in GEMPLAT arm was 9.9 months versus 2.6 moths in CAPOX. The median PFS was higher in GEMPLAT group (7.6 months) as compared to CAPOX group (1.5 months). Grade 3/4 anemia & neutropenia occurred in 3 (12%) & 2 (8%) patients in the GEMPLAT arm, respectively with no grade 3/4 hematological toxicities in CAPOX arm. Five (20%) patients developed grade 3/4 transaminitis on GEMPLAT. One (4%) patients in CAPOX arm developed sensory neuropathy and 3 (12%) have grade 3/4 skin toxicity.
In our study, the GEMPLAT regimen showed higher RR, OS and PFS as compared to CAPOX. QOL was better in the GEMPLAT arm. CAPOX regimen was better tolerated and less toxic. The main toxicity of GEMPLAT was haematological & hepatic while that of CAPEOX was dermatological. We conclude that GEMPLAT should be the standard-of-care first line palliative chemotherapy regimen for inoperable CaGB patients in good PS. Larger, multi-centre studies are needed to confirm our findings and to compare CAPOX/other regimens with GEMPLAT.
Clinical trial identification
Legal entity responsible for the study
Prof. Dr. Hemant Malhotra
All authors have declared no conflicts of interest.