Gemcitabine Plus Capecitabine Compared With Gemcitabine Alone in Advanced Pancreatic Cancer: A Randomized, Multicenter, Phase III Trial of the Swiss Group for Clinical Cancer Research and the Central European Cooperative Oncology Group

Herrmann, Richard; Bodoky, G.; Ruhstaller, Thomas; Glimelius, Bengt; Bajetta, Emilio; Schüller, J.; Saletti, Piercarlo; Bauer, Jean; Figer, Arié; Paulweber, Bernhard; Köhne, Claus‐Henning; Mingrone, Walter; Stemmer, Salomon M.; Tamás, K.; Kornek, Gabriela; Koeberle, Dieter; Cina, Susanne; Bernhard, Jürg; Dietrich, Daniel; Scheithauer, Werner

doi:10.1200/jco.2006.09.0886

Cited by 538 publications

(350 citation statements)

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“…Table 1 lists randomized phase III trials of gemcitabine combined with a second agent. [4][5][6][7][8][9][10][11][12][13][14][15][16][17] Results among the studies were similar; the addition of a chemotherapeutic agent to gemcitabine did not improve overall survival or quality of life compared with single-agent gemcitabine, with the possible exceptions of gemcitabine plus capecitabine and gemcitabine plus a platinum agent.…”

Section: Gemcitabine In Combination Trialsmentioning

confidence: 99%

“…In a subgroup of patients with good performance status, the median overall survival was improved significantly in the GEM/CAP arm. 16 In another randomized phase III trial, this gemcitabine/capecitabine combination demonstrated a significant improvement in overall survival. Cunningham et al 17 have presented this study only in abstract format at the 2005 European Cancer Conference.…”

Section: Gemcitabine Plus Capecitabinementioning

confidence: 99%

“…Gemcitabine + bevacizumab 11 4.9 5.8 Gemcitabine + cetuximab 12 3.5 6.4 Gemcitabine ± marimastat 10 NA 5.5 Gemcitabine ± tipifarnib 9 3.7 6.4 Gemcitabine ± exatecan 13 3.7 6.7 Gemcitabine ± irinotecan 7 3.4 6.3 Gemcitabine ± pemetrexed 8 3.3 6.2 Gemcitabine ± 5-FU bolus 5 3.4 6.7 Gemcitabine ± capecitabine 14 5.7 9.0 Gemcitabine + capecitabine 16 NA 8.4 Gemcitabine + capecitabine 17 NA 7.4 Gemcitabine ± 5-FU/leucovorin 15 4.9 5.9 Gemcitabine ± cisplatin 6 5.3 7.5 Gemcitabine ± oxaliplatin 4 5.8 5.9 Table 1.…”

Section: Studymentioning

confidence: 99%

“…Herrmann et al 16,19 conducted a phase III trial of gemcitabine plus capecitabine (GEM/ CAP) that included 316 patients who were randomized to two arms: (1) GEM/CAP as oral capecitabine 650 mg/m 2 daily on days 1 through 14 plus gemcitabine 1,000 mg/m 2 on days 1 and 8 of every 3 weeks or (2) gemcitabine alone. The overall survival was 8.4 months in the GEM/CAP arm vs 7.2 months in the gemcitabine alone arm.…”

Section: Gemcitabine Plus Capecitabinementioning

confidence: 99%

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Cancer of the Pancreas: Are we Making Progress? A Review of Studies in the US Oncology Research Network

2008

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Risk factors for cancer of the pancreas include age (50 years and older), male sex, race (black), smoking, a diet high in meats and fat, presence of diabetes or chronic pancreatitis, exposure to chemicals in the workplace, and a family history.Most cases of pancreatic cancer are advanced at the time of diagnosis. Usually by the time symptoms are present, pancreatic tumors are typically unresectable, and there are no curative options. Only about 10% to 15% of patients who present with pancreatic cancer are considered eligible for resection. The tumor must be localized and not invade adjacent vascular structures such as the portal vein, celiac axis, superior mesenteric artery or vein, or the hepatic artery. Determination of resectability typically involves a computed tomography (CT) scan of the abdomen and pelvis as well as endoscopic retrograde cholangiopancreatography (ERCP) IntroductionPancreatic cancer is the fourth leading cause of cancer deaths in the United States. In 2008, an estimated 37,680 people will be diagnosed with pancreatic cancer in the United States, and 34,290 will die of the disease. 1 Only 23% of patients with cancer of the exocrine pancreas will survive for 1 year, while about 4% will survive for 5 years. Cancer of the Pancreas: Are We Making Progress? A Review of Studies in the US Oncology Research Network

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Section: Gemcitabine In Combination Trialsmentioning

confidence: 99%

Section: Gemcitabine Plus Capecitabinementioning

confidence: 99%

Section: Studymentioning

confidence: 99%

Section: Gemcitabine Plus Capecitabinementioning

confidence: 99%

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Cancer of the Pancreas: Are we Making Progress? A Review of Studies in the US Oncology Research Network

2008

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“…In advanced or metastatic pancreatic cancer, combinations of gemcitabine plus 5-fluorouracil (5-FU) [4], cisplatin [5], oxaliplatin [6] and irinotecan [7] have not shown significant benefit in overall survival compared to single-agent gemcitabine. Capecitabine, an orally administered fluoropyrimidine carbamate which converts to active 5-FU in the tumour site demonstrates efficacy in untreated advanced colorectal carcinoma [8] and the combination of gemcitabine and capecitabine in advanced pancreatic cancer improves overall survival, clinical benefit response and quality of life at a statistically significant level compared with standard gemcitabine treatment [9,10]. Reports of expression of the ErbB receptor family, including the epidermal growth factor receptor (EGFR; ErbB1/HER1) and HER2; ErbB2/neu vary widely in PDAC.…”

Section: Introductionmentioning

confidence: 99%

EGFR and HER2 inhibition in pancreatic cancer

et al. 2012

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Summary The aim of this study was to investigate the effect of lapatinib, a selective inhibitor of EGFR/HER2 tyrosine kinases, on pancreatic cancer cell lines both alone and in combination with chemotherapy. Two cell lines, BxPc-3 and HPAC, displayed the greatest sensitivity to lapatinib (IC 50 < 2 μM). Lapatinib also demonstrated some activity in three KRas mutated pancreatic cancer cell lines which displayed resistance to erlotinib. Drug effect/combination index (CI) isobologram analysis was used to study the interactions of lapatinib with gemcitabine, cisplatin and 5'deoxy-5'fluorouridine. Concentration-dependent anti-proliferative effects of lapatinib in combination with chemotherapy were observed. To evaluate the potential effect of lapatinib in pancreatic cancer tumours, and to identify a subset of patient most likely to benefit from lapatinib, expression of EGFR and HER2 were investigated in 72 pancreatic cancer tumour specimens by immunohistochemistry. HER2 membrane expression was observed in only 1 % of cases, whereas 44 % of pancreatic tumours expressed EGFR. Based on our in vitro results, lapatinib may provide clinical benefit in EGFR positive pancreatic ductal adenocarcinoma.

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Comparative Outcomes of First-Line Chemotherapy for Metastatic Pancreatic Cancer Among the Regimens Used in Japan

et al. 2022

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IMPORTANCE Various first-line chemotherapy treatment regimens for patients with metastatic pancreatic cancer have been approved in Japan, including gemcitabine (GEM); fluorouracil, leucovorin, irinotecan, and oxaliplatin combination (FOLFIRINOX); GEM plus albumin-bound paclitaxel (GEM+NPTX), and S-1 (tegafur + gimeracil + oteracil). However, direct comparisons of these chemotherapy regimens are limited. OBJECTIVETo assess the short-term and long-term outcomes associated with first-line chemotherapy regimens for metastatic pancreatic cancer compared with chemotherapy regimens recommended in Japanese guidelines. DATA SOURCES In this systematic review and network meta-analysis, the bibliographic databases PubMed, Cochrane Library, and Web of Science, as well as medical journals published between January 1, 2002, and December 31, 2018, were searched for clinical trials comparing chemotherapy regimens. STUDY SELECTION Randomized 2-arm clinical trials evaluating first-line chemotherapy for advanced or metastatic pancreatic cancer were included. DATA EXTRACTION AND SYNTHESIS The Preferred Reporting Items for Systematic Reviews and Meta-analyses (PRISMA) Extension Statement for Reporting of Systematic Reviews IncorporatingNetwork Meta-analyses of Health Care Interventions was followed for data abstractions. Data were pooled using a random-effects model. The SIGN 50 Quality Assessment Instrument was used to assess the risk of bias and overall study quality of the selected trials. MAIN OUTCOMES AND MEASURESThe primary end point was overall survival (OS), and the secondary end point was progression-free survival (PFS) compared with GEM for first-line chemotherapy for metastatic pancreatic cancer. The Kaplan-Meier curve of GEM from the literature and the estimated hazard ratios (HRs) were used to model the long-term associations to calculate the area under the curve (AUC) (person-months) for OS and PFS of each chemotherapy. Sensitivity analyses with multiple functional models were conducted to confirm the long-term estimations. RESULTS A total of 22 regimens (25 studies) for OS and a total of 18 regimens (21 studies) for PFS were identified from literature. The total number of participants was 10 186, with 5856 male (57.5%) and 4330 female (42.5%). The FOLFIRINOX and GEM+NPTX regimens were associated with reduction in the risk of death, with an HR of 0.57 (95% CI, 0.41-0.79) and 0.72 (95% CI, 0.55-0.95) compared with GEM, respectively. The curve estimation also showed that FOLFIRINOX had the largest AUC for survival at 15.49 person-months (range, 13.84-15.51 person-months), followed by (continued) Key Points Question What are the comparative short-term and long-term outcomes associated with first-line chemotherapy regimens for patients with metastatic pancreatic cancer, and how do they compare with chemotherapy regimens recommended in Japanese guidelines? Findings In this systematic review and network meta-analysis of 25 randomized clinical trials assessing firstline chemotherapy regimens for advanced or metastatic pancreati...

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Gemcitabine Plus Capecitabine Compared With Gemcitabine Alone in Advanced Pancreatic Cancer: A Randomized, Multicenter, Phase III Trial of the Swiss Group for Clinical Cancer Research and the Central European Cooperative Oncology Group

Cited by 538 publications

References 29 publications

Cancer of the Pancreas: Are we Making Progress? A Review of Studies in the US Oncology Research Network

Cancer of the Pancreas: Are we Making Progress? A Review of Studies in the US Oncology Research Network

EGFR and HER2 inhibition in pancreatic cancer

Comparative Outcomes of First-Line Chemotherapy for Metastatic Pancreatic Cancer Among the Regimens Used in Japan

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