Dataset Information

Long-Term Response to Gemcitabine, Cisplatin, and Nab-Paclitaxel Followed by Maintenance Therapy for Advanced Gallbladder Cancer: A Case Report and Literature Review.

ABSTRACT:

Background

Gallbladder cancer (GBC) is the most common and devastating tumor type of biliary tract cancer (BTC) with poor outcomes. A new combined regimen of gemcitabine, cisplatin, plus nab-paclitaxel is currently considered an effective option for patients with advanced BTC following the results of a phase II trial. In addition, maintenance therapy after first-line treatment has been shown to improve disease control rate of various solid tumors but has not been evaluated for GBC patients. The scenario we report herein is of a metastatic GBC patient treated with the triple-drug regimen followed by maintenance therapy with capecitabine or S-1, who achieved a long-term survival benefit.

Case presentation

A 68-year-old man was diagnosed with gallbladder adenocarcinoma with liver, supra-diaphragmatic, and abdominal lymph node metastases (cT3N2M1, stage IVB). Partial response (PR) was achieved after five cycles of gemcitabine and cisplatin chemotherapy. A further three cycles of nab-paclitaxel plus gemcitabine-cisplatin regimen yielded a complete response of all tumor lesions. Subsequent administration of maintenance therapy with capecitabine followed by S-1 achieved a disease-free survival of 15 months for the patient. Moreover, the patient remained responsive to this triple-drug regimen when the disease progressed, achieving PR after two cycles of chemotherapy. Overall, the treatment regimens were well tolerated with no grade 3 or higher adverse effects occurring. Notably, the serum carbohydrate antigen 199 (CA199) levels were closely related to the treatment response and increased before the lesions were found on PET-CT during follow-up.

Conclusion

Our findings suggested that adding nab-paclitaxel into gemcitabine-cisplatin regimen may result in a favorable efficacy in patients with advanced GBC. Further maintenance therapy with capecitabine or S-1 after first-line therapy appeared to be a reasonable option for these patients, and it is valuable to monitor CA199 levels during treatment and follow-up.

SUBMITTER: Liu T

PROVIDER: S-EPMC8523915 | biostudies-literature | 2021

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Long-Term Response to Gemcitabine, Cisplatin, and Nab-Paclitaxel Followed by Maintenance Therapy for Advanced Gallbladder Cancer: A Case Report and Literature Review.

Liu Ting T Li Qing Q Zhang Wenjie W Zhu Qing Q

Frontiers in oncology 20211005

<h4>Background</h4>Gallbladder cancer (GBC) is the most common and devastating tumor type of biliary tract cancer (BTC) with poor outcomes. A new combined regimen of gemcitabine, cisplatin, plus nab-paclitaxel is currently considered an effective option for patients with advanced BTC following the results of a phase II trial. In addition, maintenance therapy after first-line treatment has been shown to improve disease control rate of various solid tumors but has not been evaluated for GBC patien ...[more]

PMID: 34676166

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Project description:ImportanceAdministration of gemcitabine-cisplatin, the current standard therapy for advanced biliary tract cancers, results in median progression-free survival and overall survival of 8.0 and 11.7 months, respectively. New treatments offering improved survival outcomes are therefore needed.ObjectiveTo evaluate the association between progression-free survival and the addition of nanoparticle albumin-bound (nab)-paclitaxel to gemcitabine-cisplatin for the treatment of patients with advanced biliary tract cancer.Design, setting, and participantsThis open-label, single-arm, phase 2 clinical trial conducted at the University of Texas MD Anderson Cancer Center and the Mayo Clinic in Phoenix, Arizona, enrolled 62 patients with advanced biliary tract cancers between April 14, 2015, and April 24, 2017.InterventionsPatients initially received gemcitabine, 1000 mg/m2, cisplatin, 25 mg/m2, and nab-paclitaxel, 125 mg/m2, on days 1 and 8 of 21-day cycles. Owing to hematologic adverse events among the first 32 patients enrolled, these starting doses were reduced to 800, 25, and 100 mg/m2, respectively, for the remaining 28 patients.Main outcomes and measuresThe primary trial end point was investigator-assessed progression-free survival in the intention-to-treat population.ResultsOf 60 patients who started treatment, the mean (SD) age was 58.4 (11.0) years, 38 (63%) had intrahepatic cholangiocarcinoma, 9 (15%) had extrahepatic cholangiocarcinoma, 13 (22%) had gallbladder cancer, 47 (78%) had metastatic disease, and 13 (22%) had locally advanced disease. Median follow-up was 12.2 (95% CI, 9.4-19.4) months, and median progression-free survival was 11.8 (95% CI, 6.0 to 15.6) months. The partial response rate was 45%, and the disease control rate was 84%. Median overall survival was 19.2 months (95% CI, 13.2 months to not estimable). Patients in the safety population (n = 57) received a median of 6 (interquartile range, 3-11) cycles of treatment; 26 patients (46%) remained on their starting dose throughout the trial. Grade 3 or higher adverse events occurred in 58% of patients, and 9 patients (16%) withdrew owing to adverse events. Neutropenia was the most common grade 3 or higher adverse event, occurring in 19 patients (33%) overall. Post hoc analyses showed that treatment efficacy was not significantly associated with starting dose, tumor type, or disease status and that tolerability was improved with reduced- vs high-dose treatment.Conclusions and relevanceTreatment with nab-paclitaxel plus gemcitabine-cisplatin prolonged median progression-free survival and overall survival vs those reported for historical controls treated with gemcitabine-cisplatin alone. These findings will be tested in a phase 3 randomized clinical trial.Trial registrationClinicalTrials.gov identifier: NCT02392637.

Project description:Background and purposeA phase 2 study LAPACT indicated nab-paclitaxel plus gemcitabine (AG) improved outcomes of patients with locally advanced pancreatic cancer (LAPC). Conventional radiotherapy failed to show benefit, indicating high dose to volume with high risk of recurrence is needed. The high dose can be delivered through hypofractionated tomotherapy with simultaneous integrated boost (SIB). However, there is a lack of such prospective trials and more data are needed to validate the role of AG plus hypofractionated tomotherapy with SIB in patients with LAPC.Materials and methodsPatients with LAPC receiving AG plus tomotherapy at the Nanjing Drum Tower Hospital between 2018 and 2021 were retrospectively analyzed. The treatment was scheduled as follows: nab-paclitaxel 125 mg/m2 plus gemcitabine 1,000 mg/m2 on days 1 and 8 every three weeks for at least two cycles, followed by hypofractionated tomotherapy with SIB (high dose field: 50 Gy/10 fractions, the remainder: 30 Gy/10 fractions). Then patients were given AG until intolerance or disease progression.ResultsOverall, 22 patients completing the chemoradiotherapy were included. The median follow-up was 15.2 months. After the chemoradiotherapy, 5 patients achieved a partial response (PR), 15 had a stable disease (SD), and another 2 patients were with progressive disease (PD). The median progression-free survival (PFS) and overall survival (OS) were 12.8 months (95% confidence interval [CI] 4.3-21.3 months) and 16.3 months (95% CI 10.9-21.6 months), respectively. The optimal carbohydrate antigen (CA) 19-9 response and chemotherapy cycles ≥6 were correlated with favorable PFS and OS. The most common recurrent pattern was peritoneal dissemination (22.7%) and the locoregional recurrence rate was relatively low (4.5%). Treatments were well-tolerated. The most common grade ≥3 adverse event was thrombocytopenia (13.6%).ConclusionThis study demonstrated the feasibility of AG followed by hypofractionated tomotherapy with SIB in patients with LAPC. The hypofractionated tomotherapy with SIB was safe and showed high local control rate. Further study with a larger population to validate our data is underway.

Project description:BackgroundA recent phase II trial reported prolonged survival in patients with advanced biliary tract cancer (BTC) following treatment with nab-paclitaxel plus gemcitabine-cisplatin (Gem/Cis/nab-P). We aimed to evaluate the clinical outcomes of Gem/Cis/nab-P in Asian patients with advanced BTC in a real-world setting.MethodsWe reviewed the data of patients who received Gem/Cis/nab-P for the management of advanced BTC between September 2019 and April 2021 at four institutes in Korea. Patients were classified into the Gem/Cis/nab-P and nab-P addition groups depending on the starting point of nab-P administration.ResultsA total of 178 patients treated with Gem/Cis/nab-P were included in the study. Of these, 43.8% had intrahepatic cholangiocarcinoma (CCA), 34.8% had extrahepatic CCA, and 21.3% had gall bladder cancer. A total of 117 (65.7%) patients received Gem/Cis/nab-P as the first-line treatment, while 61 (34.3%) were treated with gemcitabine-cisplatin-based chemotherapy followed by nab-P addition. The objective response rate (ORR) and disease control rate in all patients were 42.1% and 84.8%, respectively. The ORR in the Gem/Cis/nab-P group was 47.9%, while that in the nab-P addition group was 31.1%. The median progression-free survival and overall survival were 8.5 months [95% confidence interval (CI), 6.9-10.1] and 14.6 months (95% CI, 10.2-19.0), respectively. In patients who received Gem/Cis/nab-P as initial treatment, the median PFS was 9.4 months (95% CI, 7.9-10.9) and the median OS was not-reached (95% CI, not available). Anemia (n = 42, 23.6%), neutropenia (n = 40, 22.5%), and thrombocytopenia (n = 16, 9.0%) were the most common grade 3-4 toxicities. A total of 20 patients (11.2%) had conversions from unresectable to resectable disease and underwent surgery with curative intent.ConclusionGem/Cis/nab-P showed favorable real-life efficacy and safety outcomes in Korean patients with advanced BTC, which was consistent with the phase II trial outcomes.

Dataset Information

Long-Term Response to Gemcitabine, Cisplatin, and Nab-Paclitaxel Followed by Maintenance Therapy for Advanced Gallbladder Cancer: A Case Report and Literature Review.

Background

Case presentation

Conclusion

Publications

Long-Term Response to Gemcitabine, Cisplatin, and Nab-Paclitaxel Followed by Maintenance Therapy for Advanced Gallbladder Cancer: A Case Report and Literature Review.

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