Capecitabine with/without mitomycin C: results of a randomized phase II trial of second-line therapy in advanced biliary tract adenocarcinoma

Cereda, Stefano; Milella, Michèle; Cordio, S.; Leone, Francesco; Aprile, Giuseppe; Galiano, Antonella; Mosconi, S.; Vasile, Enrico; Santini, Daniele; Belli, Carmen; Amato, Alessandra; Novarino, Anna; Vaccaro, Vanja; Martines, C.; Marino, Donatella; Lutrino, Stefania Eufemia; Palazzo, Vincenzo; Reinach, Benedetta; Aldrighetti, Luca; Reni, Michele

doi:10.1007/s00280-015-2919-0

Cited by 12 publications

(8 citation statements)

References 30 publications

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“…In previous studies, the reported response rates were 2-12% for target therapies and 7-10% for salvage cytotoxic chemotherapies 25-28. Recently, Cereda et al reported that capecitabine with or without mitomycin had a response rate of 3% in a randomized phase II study of a second-line therapy in patients with BTC 24. Considering data from other previous studies, the efficacy of XELOX was slightly better or similar.…”

Section: Discussionmentioning

confidence: 91%

“…Thus, a tolerable, feasible, and useful second-line treatment is needed for these patients. There have been several studies investigating potential treatments23,24; however, a standard second-line or salvage treatment has not been established for BTCs. This prospective study suggests that capecitabine plus oxaliplatin might be useful as a second-line therapy in BTCs refractory to the standard GP regimen.…”

Section: Discussionmentioning

confidence: 99%

“…Further, a retrospective analysis of various second-line therapies in BTC showed the median PFS of 3.2 months 23. Although there is no standard data of median PFS for the second-line setting in BTCs, we considered a median PFS of 12 or more weeks as the cut-off of usefulness based on the data from these previous studies 23,24. Herein, we demonstrated that the PFS of XELOX was a median of 15.4 weeks (3.8 months).…”

Section: Discussionmentioning

confidence: 99%

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Capecitabine plus Oxaliplatin as a Second-Line Therapy for Advanced Biliary Tract Cancers: A Multicenter, Open-Label, Phase II Trial

Kim

Lee

et al. 2019

J. Cancer

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Background: Although biliary tract cancer (BTC) has a very aggressive nature, some patients maintain a relatively good performance status after failure with first-line treatment of gemcitabine plus cisplatin (GC). Thus, tolerable, feasible, and useful second-line treatments are needed for these patients. We investigated the efficacy of capecitabine plus oxaliplatin (XELOX) as a second-line therapy for patients with advanced BTC who failed first-line GC treatment.Methods: In this prospective, phase II trial, we investigated XELOX (capecitabine 1,000 mg/m2 twice daily on days 1-14 and oxaliplatin 130 mg/m2 on day 1) as a second-line treatment, given every 3 weeks, totaling 8 cycles in patients with metastatic BTC who failed first-line GC treatment. The primary outcome was progression-free survival (PFS).Results: From December 2015 to November 2016, 50 patients with metastatic intrahepatic or extrahepatic cholangiocarcinoma or gall bladder (GB) cancer were enrolled. The regimen was well tolerated. Toxicities mainly consisted of grade 1 or 2 events, and thrombocytopenia and neuropathy had the highest incidence. In intent-to-treat analysis, one complete response (CR) and six partial responses (PRs) were recorded with XELOX treatment. The overall response rate and the disease control rate from the intent-to-treat analysis were 14% and 52%, respectively. With a median follow-up of 15.6 months, PFS after XELOX was a median of 15.4 weeks (95% CI, 8.5-22.3). This PFS value supported the statistical hypothesis of this study. The median overall survival was 32.7 weeks (95% CI, 21.4-43.9).Conclusion: This phase II trial showed that XELOX treatment was efficacious and had a tolerable toxicity profile in patients with advanced BTC who failed first-line treatment of gemcitabine and cisplatin.

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Section: Discussionmentioning

confidence: 91%

Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

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Capecitabine plus Oxaliplatin as a Second-Line Therapy for Advanced Biliary Tract Cancers: A Multicenter, Open-Label, Phase II Trial

Kim

Lee

et al. 2019

J. Cancer

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“…10 Until 2019, there was no recommended regimen in this setting and the type of chemotherapy regimen varied according to the center/national clinical practices. 2,3 Following the presentation of the 10% with capecitabine plus mitomycine C. 16 In Asian countries, three single-arm phase II trials with S-1 monotherapy after progression on L1 chemotherapy suggested that this compound was safe and moderately efficacious in L2. [17][18][19] Retrospective cohorts and meta-analyses reported conflicting results about the efficacy of FP doublets vs monotherapy.…”

Section: Discussionmentioning

confidence: 99%

Fluropyrimidine single agent or doublet chemotherapy as second line treatment in advanced biliary tract cancer

Neuzillet¹,

Casadei-Gardini

Brieau

et al. 2020

Intl Journal of Cancer

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Fluoropyrimidine (FP) plus platinum chemotherapy has been recently established as a second-line (L2) preferred option in advanced biliary tract cancer (aBTC) (ABC-06 phase III trial). However, the overall survival (OS) benefit was limited and comparison with FP monotherapy was not available. Our aim was to assess the OS of patients treated with a FP monotherapy compared to a doublet with irinotecan or platinum in L2. We performed a retrospective analysis of two large multicenter prospective cohorts: a French cohort (28 centers) and an Italian cohort (9 centers). All consecutive patients with aBTC receiving FP-based L2 after gemcitabine plus cisplatin/ gemcitabine plus oxaliplatin L1 between 2003 and 2016 were included. A subgroup analysis according to performance status (PS) and an exploratory analysis according to platinum sensitivity in L1 were planned. In the French cohort (n = 351), no significant OS difference was observed between the FP monotherapy and doublet groups (median OS: 5.6 vs 6.8 months, P = .65). Stratification on Eastern Cooperative Oncology Group (ECOG) PS showed similar results in PS 0-1 and 2. Median OS was not different between FP monotherapy, platinum-and irinotecan-based doublets (5.6 vs 7.1 vs 6.7 months, P = .68). Similar findings were observed in the Italian cohort (n = 174) and in the sensitivity analysis in pooled cohorts (n = 525). No L2 regimen seemed superior over others in the platinum resistant/refractory or sensitive subgroups. Our results suggest that FP monotherapy is as active as FP doublets in aBTC in L2, regardless of the patient PS and country, and could be a therapeutic option in this setting.

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“…Fluoropyrimidines such as 5‐fluorouracil, capecitabine and S‐1 are commonly used in clinical practice. Second‐line chemotherapy, including the combination of mitomycin C and capecitabine vs. capecitabine alone, yielded a disappointing outcome, with the addition of mitomycin C failing to show improved results 24 . A randomized phase II study focusing on the efficacy of the second‐line oxaliplatin plus irinotecan (XELIRI) regimen versus that of irinotecan monotherapy demonstrated a clear progression‐free survival (PFS) benefit 25 .…”

Section: Systemic Therapymentioning

confidence: 99%

Therapy for advanced cholangiocarcinoma: Current knowledge and future potential

Wang

Chen

Guo

et al. 2020

J Cellular Molecular Medi

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Cholangiocarcinoma (CCA) is the second most commonly occurring primary hepatobiliary cancer, accounting for 10%-20% of all primary hepatic carcinomas. 1,2 The 5-year relative survival rates range from 2% to 15% for intrahepatic cholangiocarcinoma (ICC) and 2%-30% for extrahepatic cholangiocarcinoma (ECC). 3 The majority of new CCA patients (60% ~ 70%) are diagnosed at a late stage and are treated with palliative therapy, particularly chemotherapy. 4,5 However, the prognoses remain unsatisfactory in such settings, despite the provision of first-line chemotherapy. When a patient's condition deteriorates following first-line chemotherapy, the recommended approach is supportive care. 6 CCA has low sensitivity to chemotherapy, and only a few effective anticancer drugs are available for its treatment. Traditionally, the occurrence of CCA is considered rare; however, the global incidence rate of the disease, particularly ICC, has steadily increased over the past 15 years. 1,7 Cholangiocarcinoma is commonly classified based on its anatomical site of presentation into the ICC and ECC subtypes. ECC is further divided into perihilar cholangiocarcinoma (PCC) and distal cholangiocarcinoma (DCC), with each subtype showing different epidemiological, molecular and therapeutic characteristics (Figure 1). Although the aetiology of CCA has not been determined, several risk factors have been identified. For example, some risk factors for ICC include primary sclerosing cholangitis (PSC), liver cirrhosis, Opisthorchis viverrine infection and Clonorchis sinensis infection, whereas PSC, gallstones and Lynch syndrome are risk factors for ECC. 8-10 Surgery is currently the most effective and preferred treatment option for CCA. However, surgical resection can be performed in only approximately 35% of patients with early-stage disease. Besides, the rate of post-operative

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Capecitabine with/without mitomycin C: results of a randomized phase II trial of second-line therapy in advanced biliary tract adenocarcinoma

Abstract: Since capecitabine yielded a disappointing outcome and the addition of mitomycin C did not improve the results, new therapeutic strategies need to be explored to improve survival in this disease setting.

Cited by 12 publications

References 30 publications

Capecitabine plus Oxaliplatin as a Second-Line Therapy for Advanced Biliary Tract Cancers: A Multicenter, Open-Label, Phase II Trial

Capecitabine plus Oxaliplatin as a Second-Line Therapy for Advanced Biliary Tract Cancers: A Multicenter, Open-Label, Phase II Trial

Fluropyrimidine single agent or doublet chemotherapy as second line treatment in advanced biliary tract cancer

Therapy for advanced cholangiocarcinoma: Current knowledge and future potential

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