Abstract
Background: Complete surgical resection of gastric cancer is potentially curative, but long-term survival is poor. Methods: Patients with histologically proven adenocarcinoma of the stomach of stages IB, II, IIIA and B, or IV (T4N2M0) and treated with potentially curative surgery were randomly assigned to follow-up alone or to intravenous treatment with four cycles (repeated every 21 days) of PELF (cisplatin [40 mg/m2, on days 1 and 5], epirubicin [30 mg/m2, days 1 and 5], L-leucovorin [100 mg/m2, days 1-4], and 5-fluorouracil [300 mg/m2, days 1-4] in a hospital setting. Frequencies and severity of adverse events were determined. Overall survival (OS) and disease-free survival (DFS) were compared between the treatment arms using Kaplan-Meier analysis and a Cox proportional hazards regression model. All statistical tests were two-sided. Results: From January 1995 through September 2000, 258 patients were randomly assigned to chemotherapy (n = 130) or surgery alone (n = 128). Patient characteristics were well balanced between the two arms. Among those who received chemotherapy, grade 3 or 4 toxic effects including vomiting, mucositis, and diarrhea were experienced by 21.1%, 8.4%, and 11.8% of patients, respectively. Leucopenia, anemia, and thrombocytopenia of grade 3 or 4 were experienced by 20.3%, 3.3%, and 4.2% of patients, respectively. After a median follow-up of 72.8 months, 128 patients (49.6%) experienced recurrence and 139 (53.9%) deaths were observed, one toxicity-related. Relative to treatment with surgery alone, adjuvant chemotherapy did not increase disease-free survival (hazard ratio [HR] of recurrence = 0.92; 95% confidence interval [CI] = 0.66 to 1.27) or overall survival (HR of death = 0.90; 95% CI = 0.64 to 1.26). Conclusions: Our results failed to provide proof of an effect of adjuvant chemotherapy with PELF on overall survival or disease-free survival. The estimated effect of chemotherapy (10% reduction in the hazard of death or relapse) is modest and consistent with the results of meta-analyses of adjuvant chemotherapy without platinum agents.
| Original language | English |
|---|---|
| Pages (from-to) | 388-398 |
| Number of pages | 11 |
| Journal | Journal of the National Cancer Institute |
| Volume | 100 |
| Issue number | 6 |
| DOIs | |
| Publication status | Published - Mar 2008 |
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ASJC Scopus subject areas
- Cancer Research
- Oncology
Cite this
Adjuvant chemotherapy in completely resected gastric cancer : A randomized phase III trial conducted by GOIRC. / Di Costanzo, Francesco; Gasperoni, Silvia; Manzione, Luigi; Bisagni, Giancarlo; Labianca, Roberto; Bravi, Stefano; Cortesi, Enrico; Carlini, Paolo; Bracci, Raffaella; Tomao, Silverio; Messerini, Luca; Arcangeli, Annarosa; Torri, Valter; Bilancia, Domenico; Floriani, Irene; Tonato, Maurizio.
In: Journal of the National Cancer Institute, Vol. 100, No. 6, 03.2008, p. 388-398.Research output: Contribution to journal › Article
}
TY - JOUR
T1 - Adjuvant chemotherapy in completely resected gastric cancer
T2 - A randomized phase III trial conducted by GOIRC
AU - Di Costanzo, Francesco
AU - Gasperoni, Silvia
AU - Manzione, Luigi
AU - Bisagni, Giancarlo
AU - Labianca, Roberto
AU - Bravi, Stefano
AU - Cortesi, Enrico
AU - Carlini, Paolo
AU - Bracci, Raffaella
AU - Tomao, Silverio
AU - Messerini, Luca
AU - Arcangeli, Annarosa
AU - Torri, Valter
AU - Bilancia, Domenico
AU - Floriani, Irene
AU - Tonato, Maurizio
PY - 2008/3
Y1 - 2008/3
N2 - Background: Complete surgical resection of gastric cancer is potentially curative, but long-term survival is poor. Methods: Patients with histologically proven adenocarcinoma of the stomach of stages IB, II, IIIA and B, or IV (T4N2M0) and treated with potentially curative surgery were randomly assigned to follow-up alone or to intravenous treatment with four cycles (repeated every 21 days) of PELF (cisplatin [40 mg/m2, on days 1 and 5], epirubicin [30 mg/m2, days 1 and 5], L-leucovorin [100 mg/m2, days 1-4], and 5-fluorouracil [300 mg/m2, days 1-4] in a hospital setting. Frequencies and severity of adverse events were determined. Overall survival (OS) and disease-free survival (DFS) were compared between the treatment arms using Kaplan-Meier analysis and a Cox proportional hazards regression model. All statistical tests were two-sided. Results: From January 1995 through September 2000, 258 patients were randomly assigned to chemotherapy (n = 130) or surgery alone (n = 128). Patient characteristics were well balanced between the two arms. Among those who received chemotherapy, grade 3 or 4 toxic effects including vomiting, mucositis, and diarrhea were experienced by 21.1%, 8.4%, and 11.8% of patients, respectively. Leucopenia, anemia, and thrombocytopenia of grade 3 or 4 were experienced by 20.3%, 3.3%, and 4.2% of patients, respectively. After a median follow-up of 72.8 months, 128 patients (49.6%) experienced recurrence and 139 (53.9%) deaths were observed, one toxicity-related. Relative to treatment with surgery alone, adjuvant chemotherapy did not increase disease-free survival (hazard ratio [HR] of recurrence = 0.92; 95% confidence interval [CI] = 0.66 to 1.27) or overall survival (HR of death = 0.90; 95% CI = 0.64 to 1.26). Conclusions: Our results failed to provide proof of an effect of adjuvant chemotherapy with PELF on overall survival or disease-free survival. The estimated effect of chemotherapy (10% reduction in the hazard of death or relapse) is modest and consistent with the results of meta-analyses of adjuvant chemotherapy without platinum agents.
AB - Background: Complete surgical resection of gastric cancer is potentially curative, but long-term survival is poor. Methods: Patients with histologically proven adenocarcinoma of the stomach of stages IB, II, IIIA and B, or IV (T4N2M0) and treated with potentially curative surgery were randomly assigned to follow-up alone or to intravenous treatment with four cycles (repeated every 21 days) of PELF (cisplatin [40 mg/m2, on days 1 and 5], epirubicin [30 mg/m2, days 1 and 5], L-leucovorin [100 mg/m2, days 1-4], and 5-fluorouracil [300 mg/m2, days 1-4] in a hospital setting. Frequencies and severity of adverse events were determined. Overall survival (OS) and disease-free survival (DFS) were compared between the treatment arms using Kaplan-Meier analysis and a Cox proportional hazards regression model. All statistical tests were two-sided. Results: From January 1995 through September 2000, 258 patients were randomly assigned to chemotherapy (n = 130) or surgery alone (n = 128). Patient characteristics were well balanced between the two arms. Among those who received chemotherapy, grade 3 or 4 toxic effects including vomiting, mucositis, and diarrhea were experienced by 21.1%, 8.4%, and 11.8% of patients, respectively. Leucopenia, anemia, and thrombocytopenia of grade 3 or 4 were experienced by 20.3%, 3.3%, and 4.2% of patients, respectively. After a median follow-up of 72.8 months, 128 patients (49.6%) experienced recurrence and 139 (53.9%) deaths were observed, one toxicity-related. Relative to treatment with surgery alone, adjuvant chemotherapy did not increase disease-free survival (hazard ratio [HR] of recurrence = 0.92; 95% confidence interval [CI] = 0.66 to 1.27) or overall survival (HR of death = 0.90; 95% CI = 0.64 to 1.26). Conclusions: Our results failed to provide proof of an effect of adjuvant chemotherapy with PELF on overall survival or disease-free survival. The estimated effect of chemotherapy (10% reduction in the hazard of death or relapse) is modest and consistent with the results of meta-analyses of adjuvant chemotherapy without platinum agents.
UR - http://www.scopus.com/inward/record.url?scp=41449091327&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=41449091327&partnerID=8YFLogxK
U2 - 10.1093/jnci/djn054
DO - 10.1093/jnci/djn054
M3 - Article
C2 - 18334706
AN - SCOPUS:41449091327
VL - 100
SP - 388
EP - 398
JO - Journal of the National Cancer Institute
JF - Journal of the National Cancer Institute
SN - 0027-8874
IS - 6
ER -