Front-line treatment of inoperable or metastatic pancreatic cancer with gemcitabine and capecitabine: an intergroup, multicenter, phase II study

Stathopoulos, Georgios; Syrigos, Kostas; Polyzos, Aristidis; Fountzilas, George; Rigatos, Sotiris K.; Ziras, Nikolaos; Potamiannou, A.; Tsiakopoulos, I.; Androulakis, Nikolaos; Aravantinos, G.; Athanasiadis, A.; Papakotoulas, Pavlos; Georgoulias, Vassilis

doi:10.1093/annonc/mdh065

Cited by 56 publications

(41 citation statements)

References 18 publications

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“…Toxicity from treatment in our study was consistent with previous trials [8][9][10]. Grade 4 toxicity was not found and grade 2-3 toxicity was well controlled.…”

Section: Toxicitysupporting

confidence: 91%

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Preliminary results of phase II study of capecitabine and gemcitabine (CAP-GEM) in patients with metastatic pretreated thymic epithelial tumors (TETs)

et al. 2010

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Background: No previous prospective trials have been reported with capecitabine and gemcitabine (CAP-GEM) in patients with metastatic thymic epithelial tumors (TETs). We conducted a multicenter study to determine the activity and tolerability of this regimen in pretreated TETs.Patients and methods: A total of 15 patients were enrolled in the first stage of phase II study. All patients received CAP-GEM every 3 weeks. The primary end point was objective response rate (RR); secondary end points were toxicity, progression-free survival (PFS) and overall survival.Results: Complete responses (CR) and partial responses were observed in three (20%) and three (20%) patients for a 40% RR, respectively. Grade 1-2 neutropenia, anemia and thrombocytopenia were the most common side-effects, noted in seven (46.7%), five (33.3%) and five (33.3%) patients, respectively. The most common grade 3 toxicity was neutropenia in three patients (20%). Median PFS was 11 months (95% confidence interval 4-17). The 1-and 2-year survival rates were 80% and 67%, respectively. Conclusion:We have decided to publish the preliminary results because this regimen was more active than that expected. Although our results are preliminary, CAP-GEM shows activity and safety in pretreated TETs. Furthermore, multicenter trials, also in first-line setting, are necessary to confirm our results.

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“…Toxicity from treatment in our study was consistent with previous trials [8][9][10]. Grade 4 toxicity was not found and grade 2-3 toxicity was well controlled.…”

Section: Toxicitysupporting

confidence: 91%

“…Various studies, especially in gastrointestinal tumors, showed that capecitabine and gemcitabine (CAP-GEM) combination was active and well tolerated [6][7][8][9][10].…”

Section: Introductionmentioning

confidence: 99%

Preliminary results of phase II study of capecitabine and gemcitabine (CAP-GEM) in patients with metastatic pretreated thymic epithelial tumors (TETs)

et al. 2010

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“…Numerous phase II studies have investigated combinations of these active drugs with or without gemcitabine in patients with advanced/metastatic pancreatic cancer (Rothenberg et al, 1998;Bahadori et al, 1999;Hidalgo et al, 1999;Rocha-Lima et al, 1999;Heinemann et al, 2000;Stathopoulos et al, 2001;Alberts et al, 2002;Berlin et al, 2002;Hess et al, 2003;Stathopoulos et al, 2003;Ulrich-Pur et al, 2003). The combination of gemcitabine plus irinotecan has resulted in an objective response of 25% with a median overall survival ranging from 5.7 to 7 months (Rocha-Lima et al, 2002;Stathopoulos et al, 2004). As phase II studies of combinations of active anticancer drugs in patients with advanced/ metastatic pancreatic cancer have been associated with a better survival (about 7 months) (Rocha-Lima et al, 2002;Stathopoulos et al, 2003;Stathopoulos et al, 2004) compared with gemcitabine monotherapy (about 5 months) (Miller et al, 1981), various randomised trials are ongoing in order to validate these observations.…”

mentioning

confidence: 99%

“…The combination of gemcitabine plus irinotecan has resulted in an objective response of 25% with a median overall survival ranging from 5.7 to 7 months (Rocha-Lima et al, 2002;Stathopoulos et al, 2004). As phase II studies of combinations of active anticancer drugs in patients with advanced/ metastatic pancreatic cancer have been associated with a better survival (about 7 months) (Rocha-Lima et al, 2002;Stathopoulos et al, 2003;Stathopoulos et al, 2004) compared with gemcitabine monotherapy (about 5 months) (Miller et al, 1981), various randomised trials are ongoing in order to validate these observations.…”

mentioning

confidence: 99%

A multicenter phase III trial comparing irinotecan-gemcitabine (IG) with gemcitabine (G) monotherapy as first-line treatment in patients with locally advanced or metastatic pancreatic cancer

et al. 2006

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Our purpose was to determine the response rate and median and overall survival of gemcitabine as monotherapy versus gemcitabine plus irinotecan in advanced or metastatic pancreatic cancer. Patients with histologically or cytologically confirmed adenocarcinoma who were chemotherapy and radiotherapy naive were enrolled. Patients were centrally randomised at a one-to-one ratio to receive either gemcitabine monotherapy (900 mg m À2 on days 1, 8 and 15 every 4 weeks (arm G), or gemcitabine (days 1 and 8) plus irinotecan (300 mg m À2 on day 8) (arm IG), repeated every 3 weeks. The total number of cycles administered was 255 in the IG arm and 245 in the G arm; the median number of cycles was 3. In all, 145 patients (71 in arm IG and 74 in arm G) were enrolled; 60 and 70 patients from arms IG and G, respectively, were evaluable. A complete clinical response was achieved in three (4.3%) arm G patients; nine (15%) patients in arm IG and four (5.7%) in arm G achieved a partial response. The overall response rate was: arm IG 15% and arm G 10% (95% CI 5.96 -24.04 and 95% CI 2.97 -17.03, respectively; P ¼ 0.387). The median time to tumour progression was 2.8 months and 2.9 months and median survival time was 6.4 and 6.5 months for the IG and G arms, respectively. One-year survival was 24.3% for the IG arm and 21.8% for the G arm. No statistically significant difference was observed comparing gemcitabine monotherapy versus gemcitabine plus irinotecan in the treatment of advanced pancreatic cancer, with respect to overall and 1-year survival.

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“…Capecitabine a fluoropyrimidene carbamate rationally designed as orally administered is currently approved by the FDA (Food and Drug Administration) EMA (European Medicinal Agency) and COFEPRIS (Federal Commission against Sanitary Risks, Mexico) as adjuvant in patients with colon, colorectal [1][2][3], breast [4,5], ovarian [6,7] and pancreatic [8][9][10] cancer, in combination with other antineoplasic drugs. Capecitabine a prodrug is selectively activated by tumor cells to its cytotoxic moiety, 5-fluorouracil (5-FU), by thymidine phosphorylase, which is generally expressed at high levels in tumors [11,12].…”

Section: Introductionmentioning

confidence: 99%

Bioequivalence of Two Formulations (Innovator vs Generic) of Capecitabine in Patients with Cancer of Colon

Betzabe¹,

Manuel²,

Rafael³

et al. 2015

CRJ

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Abstract:Capecitabine is an orally administered chemotherapeutic agent used in the treatment of numerous cancers including colon, colorectal, ovarian, breast and pancreatic. Considering the importance of generic drugs in Health Care Systems, it is essential that its quality, safety and efficacy be compared with the corresponding innovator product. The objective of the study was to compare the pharmacokinetics and relative bioequivalence between two tablet (500 mg) formulations of capecitabine in Mexican patients with cancer of colon. The study was designed as open, prospective, randomized, two-way, crossover bioequivalence trial. A single oral dose of 2000 mg capecitabine was administered on two separate days to 24 patients. After each administration, serial blood samples were collected for up 8 hr. The washout between the two administrations was 3 days. Capecitabine was determined in plasma using LC/MS-MS. No statistically significant differences in C max , AUC 0-t , and AUC 0-α were found between the test and innovator formulations. Both products were well tolerated by the patients, with no serious adverse events. The generic capecitabine was pharmacokinetic bioequivalent with the innovator formulations.

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Front-line treatment of inoperable or metastatic pancreatic cancer with gemcitabine and capecitabine: an intergroup, multicenter, phase II study

Abstract: In patients with pancreatic cancer, the combination of GEM with CAP is an active and well tolerated regimen that merits further evaluation in prospective randomized studies.

Cited by 56 publications

References 18 publications

Preliminary results of phase II study of capecitabine and gemcitabine (CAP-GEM) in patients with metastatic pretreated thymic epithelial tumors (TETs)

Preliminary results of phase II study of capecitabine and gemcitabine (CAP-GEM) in patients with metastatic pretreated thymic epithelial tumors (TETs)

A multicenter phase III trial comparing irinotecan-gemcitabine (IG) with gemcitabine (G) monotherapy as first-line treatment in patients with locally advanced or metastatic pancreatic cancer

Bioequivalence of Two Formulations (Innovator vs Generic) of Capecitabine in Patients with Cancer of Colon

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