Nab-paclitaxel: An effective third-line chemotherapy in patients with advanced, unresectable gallbladder cancer

Talwar, Vineet; Raina, Shubhra; Goel, Varun; Dash, Prasanta K.; Doval, Dinesh Chandra

doi:10.4103/ijmr.ijmr_930_18

Cited by 5 publications

(3 citation statements)

References 15 publications

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“…Previous studies have suggested the clinical benefit of nanoparticle albumin-bound (nab)-paclitaxel in BTC [ 3 , 4 ]. In a single-arm, multicenter trial, combination chemotherapy with capecitabine and nab-paclitaxel demonstrated feasibility as a regimen for advanced BTC in patients who had progressed on first-line chemotherapy, with a disease control rate of 80% and overall survival of 12.1 months [ 5 ].…”

Section: Introductionmentioning

confidence: 99%

Sintilimab plus nab-paclitaxel as second-line treatment for advanced biliary tract cancer: study protocol for an investigator-initiated phase 2 trial (NapaSinti trial)

Zhou,

Li,

Yang

et al. 2023

BMC Cancer

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Background Biliary tract cancer (BTC) is a relatively rare but highly aggressive malignancy. However, there is currently no satisfactory second-line regimen for patients without specific genetic mutations. Nanoparticle albumin–bound paclitaxel, also known as nab-paclitaxel (Abraxane, Bristol Myers Squibb), has shown activity in patients with BTC. Studies investigating the immunogenic features of BTC suggested that checkpoint inhibition may lead to antitumor immune responses. In recent years, improved survival has been observed in patients treated with chemotherapy combined with immunotherapy across multiple cancer types, including BTC. This clinical trial aims to evaluate the efficacy and safety of second-line sintilimab in combination with nab-paclitaxel in advanced BTC patients. Methods The NapaSinti trial is a prospective, nonrandomized, open-label, phase 2 study conducted at a tertiary hospital in Chengdu, China. Eligible patients are those with histologically or cytologically confirmed locally advanced non-resectable or metastatic adenocarcinoma in the biliary tract (including intrahepatic cholangiocarcinoma, extrahepatic cholangiocarcinoma, and gallbladder cancer), aged between 18 and 75 years, with an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1, who have experienced disease progression after prior gemcitabine- or fluorouracil-based chemotherapy and have not received taxane or immune checkpoint inhibitor treatment. Enrolled patients will receive intravenous administration of sintilimab 200 mg on day 1 and nab-paclitaxel 125 mg/m2 on days 1 and 8, every three weeks. The primary endpoint is the objective response rate (ORR), while the secondary endpoints include overall survival (OS), progression-free survival (PFS), and safety. Exploratory objectives aim to identify biomarkers and molecular signatures for predicting response or prognosis. Using Simon’s two-stage design, a total of 63 participants will be enrolled in the study. This trial was initiated in March 2022 in China. Discussion The NapaSinti trial evaluates the efficacy and safety of second-line sintilimab plus nab-paclitaxel for advanced biliary tract cancer. Additionally, the trial provides an opportunity for translational research. Trial registration Chinese Clinical Trial Registry ChiCTR2100052118. Registered October 19, 2021.

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Section: Introductionmentioning

confidence: 99%

Sintilimab plus nab-paclitaxel as second-line treatment for advanced biliary tract cancer: study protocol for an investigator-initiated phase 2 trial (NapaSinti trial)

Zhou,

Li,

Yang

et al. 2023

BMC Cancer

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“…Moreover, in a small series, nab-paclitaxel and capecitabine appeared to have a biological activity by controlling BTC with a disease control rate (DCR) of 81% (9/11), positively affecting survival in second-line treatment ( 15 ). A retrospective study suggested the clinical benefit of nab-paclitaxel monotherapy in prolonging OS in advanced GBC patients after failure of the first-line gemcitabine and platinum and the second-line FOLFOX-4 therapy ( 16 ). Overall, these data indicate that nab-paclitaxel monotherapy or nab-paclitaxel-based combination chemotherapy can provide a response in advanced GBC patients.…”

Section: Introductionmentioning

confidence: 99%

PD-1 inhibitors plus nab-paclitaxel-containing chemotherapy for advanced gallbladder cancer in a second-line setting: A retrospective analysis of a case series

Tan

Huang

et al. 2022

Front. Oncol.

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BackgroundGallbladder cancer (GBC) is a fatal cancer, and the efficacy of the current standard second-line chemotherapy for GBC is limited. Novel therapies need to be explored. This retrospective analysis was aimed to investigate the outcomes of patients treated at West China Hospital with PD-1 inhibitors combined with nab-paclitaxel-based chemotherapy (nab-paclitaxel monotherapy or nab-paclitaxel plus other cytotoxic agents) in a second-line setting.MethodsBetween April 2020 and May 2022, the patients with advanced GBC receiving PD-1 inhibitors combined with nab-paclitaxel-based chemotherapy after resistance to first-line gemcitabine-based chemotherapy at West China Hospital were retrospectively screened.ResultsEleven patients were included, and all received gemcitabine-based chemotherapy as first-line therapy. Eight patients underwent next-generation sequencing (NGS), and all had microsatellite stability (MSS) and a low tumor mutation burden (TMB). Six patients were negative for PD-L1 expression and one patient was positive for PD-L1. Therapeutically relevant genetic alterations were not found. All patients received PD-1 inhibitors in combination with nab-paclitaxel-based chemotherapy as second-line therapy. Pembrolizumab was administered in 3 patients, and sintilimab was administered in eight patients. One patient had no measurable target lesion. Complete response (CR) was observed in one (10.0%) patient, partial response (PR) in four (40%) patients, and stable disease (SD) in four (40%) patients. The median progression-free survival (PFS) was 7.5 (95% CI: 2.5-12.5) months, and the median overall survival (OS) was 12.7 (95% CI: 5.5-19.9) months. The adverse events (AEs) were manageable.ConclusionOur results suggest that PD-1 inhibitors combined with nab-paclitaxel-based chemotherapy as second-line therapy for advanced GBC might be a potential treatment and deserves further evaluation.

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“…For advanced biliary tract cancers (BTC), chemotherapy with or without ICI is the standard first-line treatment (Oh et al, 2022a). Nanoparticle albumin-bound (nab)-paclitaxel has demonstrated clinical benefits in both biliary tract cancer (BTC) and HCC (Zhou et al, 2011;Shroff et al, 2019;Talwar et al, 2020;Cheon et al, 2021). A phase 2 clinical trial has shown that treatment with nab-paclitaxel and gemcitabine-cisplatin (GC) had longer PFS and OS than GC alone (Shroff et al, 2019).…”

mentioning

confidence: 99%

Case report: Remarkable response to sintilimab, lenvatinib, and nab-paclitaxel in postoperative metastatic chemotherapy-resistant combined hepatocellular-cholangiocarcinoma

Zhou,

Lei,

Tan

et al. 2023

Front. Pharmacol.

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Background: Combined hepatocellular-cholangiocarcinoma (cHCC-CCA) is a highly aggressive malignancy with a poor prognosis. However, there are no consensus treatment guidelines, and decisions are usually extrapolated from intrahepatic cholangiocarcinoma (ICC) or hepatocellular carcinoma (HCC). Given that cHCC-CCA owns the unequivocal presence of both hepatocytic and cholangiocytic differentiation, a combination regimen of anti-PD1 antibody, multikinase inhibitor, and chemotherapy targeting against both components might be an optimal choice.Case presentation: We present the case of a patient with postoperative metastatic chemotherapy-resistant cHCC-CCA who exhibited a durable response and reasonable tolerability to a combination therapy consisting of the anti-PD1 antibody sintilimab, multikinase inhibitor lenvatinib, and nab-paclitaxel, despite having a low tumor mutational burden (TMB-L), microsatellite stability (MSS), and negative programmed cell death 1 ligand 1 (PD-L1).Conclusion: The combination regimen of immune checkpoint inhibitor sintilimab, multikinase inhibitor lenvatinib, and chemotherapy with nab-paclitaxel, which targets both the HCC and ICC components, may represent a promising treatment option for patients with cHCC-CCA. Further research is warranted to validate these findings in larger patient cohorts.

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Nab-paclitaxel: An effective third-line chemotherapy in patients with advanced, unresectable gallbladder cancer

Cited by 5 publications

References 15 publications

Sintilimab plus nab-paclitaxel as second-line treatment for advanced biliary tract cancer: study protocol for an investigator-initiated phase 2 trial (NapaSinti trial)

Sintilimab plus nab-paclitaxel as second-line treatment for advanced biliary tract cancer: study protocol for an investigator-initiated phase 2 trial (NapaSinti trial)

PD-1 inhibitors plus nab-paclitaxel-containing chemotherapy for advanced gallbladder cancer in a second-line setting: A retrospective analysis of a case series

Case report: Remarkable response to sintilimab, lenvatinib, and nab-paclitaxel in postoperative metastatic chemotherapy-resistant combined hepatocellular-cholangiocarcinoma

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