A randomized phase III study of irinotecan and cisplatin (CP) versus etoposide and cisplatin (EP) in extensive-disease small-cell lung cancer (ED-SCLC): Japan Clinical Oncology Group Study (JCOG 9511)

Negoro, Shunichi; Noda, Kazumasa; Nishiwaki, Yutaka; Kawahara, Mikako; Tamura, Tomohide; Sugiura, T; Yokayama, A; Mori, Kosuke; Fukuoka, Masahiro; Yoshimura, K.; Saijo, N

doi:10.1016/s0169-5002(00)80095-1

Cited by 27 publications

(3 citation statements)

References 0 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…Preliminary studies with irinotecan hydrochloride, a topoisomerase I inhibitor, revealed the promising outcome against SCLC and the subsequent phase II study with irinotecan and cisplatin reported a complete response rate of 29% and an overall rate of 86% in patients with ED SCLC [8,9]. Based on these initial reports, the Japanese Cooperative Oncology Group (JCOG) conducted a phase III study to compare the efficacy and toxicity of irinotecan plus cisplatin (IP) versus EP as the firstline of chemotherapy for ED-SCLC [10,11]. Median OS and 1-year survival rate were significantly higher with IP than with EP (median survival for IP vs. EP, 12.8 vs. 9.4 months, and 1-year survival rate, 58.4% vs. 37.7%).…”

Section: Introductionmentioning

confidence: 99%

Randomized Phase III Trial of Irinotecan Plus Cisplatin versus Etoposide Plus Cisplatin in Chemotherapy-Naïve Korean Patients with Extensive-Disease Small Cell Lung Cancer

Kim

et al. 2019

Cancer Res Treat

View full text Add to dashboard Cite

show abstract

Section: Introductionmentioning

confidence: 99%

Randomized Phase III Trial of Irinotecan Plus Cisplatin versus Etoposide Plus Cisplatin in Chemotherapy-Naïve Korean Patients with Extensive-Disease Small Cell Lung Cancer

Kim

et al. 2019

Cancer Res Treat

View full text Add to dashboard Cite

show abstract

“…Median survival time was 12.8 months in the IP arm compared with 9.4 months in the EP arm (p ϭ 0.002). 4,5 Hermes et al 6 also found that irinotecan plus carboplatin prolonged survival in E-SCLC with slightly better scores for quality of life. Another randomized controlled trial (RCT) showed that IP seemed to improve progression-free survival (PFS) with less toxicities than EP in patients with E-SCLC.…”

mentioning

confidence: 97%

A Meta-Analysis of Randomized Controlled Trials Comparing Irinotecan/Platinum with Etoposide/Platinum in Patients with Previously Untreated Extensive-Stage Small Cell Lung Cancer

Jiang

Liang

Zhou

et al. 2010

Journal of Thoracic Oncology

100

View full text Add to dashboard Cite

To compare the efficacy and toxicities of irinotecan/ platinum (IP) with etoposide/platinum (EP) in patients with previously untreated extensive-stage small cell lung cancer (E-SCLC). Methods: The PubMed database, the Cochrane Library, conference proceedings, databases of ongoing trials, and references of published trials and review articles were searched. Two reviewers independently assessed the quality of the trials and extracted data. The relative risk for overall response to treatment, hazard ratios (HRs) for overall survival (OS) and progression-free survival (PFS), and odds ratios for the different types of toxicity were pooled by STATA package. Results: Six trials involving 1476 patients with previously untreated E-SCLC were ultimately analyzed. The intention-totreatment analysis indicated that IP regimens could acquire more overall response than EP regimens (relative risk ϭ 1.10, 95% confidence interval ͓CI͔: 1.00 -1.21, p ϭ 0.043). The pooled HR showed that IP could prolong OS (HR ϭ 0.81, 95% CI: 0.66 -0.99, p ϭ 0.044). Nevertheless, the pooled HR failed to show a favorable PFS in IP regimens (HR ϭ 0.82, 95% CI: 0.64 -1.06, p ϭ 0.139). IP regimens led to less grade 3 to 4 anemia, neutropenia, and thrombocytopenia but more grade 3 to 4 vomiting and diarrhea than EP regimens. Treatment-related deaths were comparable between the two groups. Conclusion: Although the PFS was similar from this meta-analysis, our results suggest that IP might have an advantage in overall response and OS compared with EP with less hematological toxicities. The IP regimens may be an alternative of EP regimens in the first-line treatment of E-SCLC.

show abstract

“…Irinotecan (IRI), a topoisomerase I inhibitor, is an established chemotherapy drug with demonstrated benefit in patients with colorectal cancer . Its efficacy has also been evaluated in preclinical and clinical studies in cervical, esophageal, gastric, glioma, lung, mesothelioma, pancreatic, and advanced metastatic breast cancer. − However, in preclinical breast cancer models, IRI showed limited therapeutic activity and dose-limiting toxicity side effects. , Additional clinical trials have yielded inconclusive results regarding the optimal administration schedule and have questioned the effectiveness of IRI in treating patients with advanced metastatic breast cancers altogether. − A viable solution to increase the efficacy and decrease toxicity of a small molecule drug is nanoencapsulation. In fact, the liposomal formulation of irinotecan (nal-IRI, ONIVYDE) has demonstrated improved activity with decreased toxicity in a number of animal models of human cancer compared to nonliposomal IRI …”

Section: Introductionmentioning

confidence: 99%

Liposomal Irinotecan Achieves Significant Survival and Tumor Burden Control in a Triple Negative Breast Cancer Model of Spontaneous Metastasis

et al. 2018

View full text Add to dashboard Cite

Triple negative breast cancer (TNBC) represents a significant therapeutic challenge due to its highly aggressive nature and lack of effective treatment options. Liposomal irinotecan (nal-IRI, ONIVYDE) was approved in 2015 (by the Food and Drug Administration, European Medicines Agency, and Therapeutic Goods Administration) and is a topoisomerase inhibitor indicated, in combination with fluorouracil and leucovorin, for the treatment of patients with metastatic adenocarcinoma of the pancreas after disease progression following gemcitabine-based therapy. This study investigates the potential therapeutic benefit of nal-IRI for the treatment of advanced TNBC in a clinically relevant mouse model of spontaneous metastasis (LM2-4). Female SCID mice were orthotopically inoculated with TNBC LM2-4-luc cells in the lower mammary fat pad. Following primary tumor resection, bioluminescence imaging (BLI) was used to monitor both metastasis formation and spread as well as response to treatment with nal-IRI. Weekly treatment with 10 mg/kg of nal-IRI provided a 4.9-times longer median survival compared to both 50 mg/kg irinotecan treated and untreated animals. The survival benefit was supported by a significant delay in the regrowth of the primary tumor, effective control, and eventual regression of metastases assessed using longitudinal BLI, which was confirmed at the study end point with magnetic resonance (MR) imaging and post-mortem observation. This preclinical investigation demonstrates that, at a five-times lower dose compared to the free drug, liposomal irinotecan provides significant survival benefit and effective management of metastatic disease burden in a clinically relevant model of spontaneous TNBC metastases. These findings support the evaluation of nal-IRI in patients with advanced and metastatic TNBC.

show abstract

A randomized phase III study of irinotecan and cisplatin (CP) versus etoposide and cisplatin (EP) in extensive-disease small-cell lung cancer (ED-SCLC): Japan Clinical Oncology Group Study (JCOG 9511)

Cited by 27 publications

References 0 publications

Randomized Phase III Trial of Irinotecan Plus Cisplatin versus Etoposide Plus Cisplatin in Chemotherapy-Naïve Korean Patients with Extensive-Disease Small Cell Lung Cancer

Randomized Phase III Trial of Irinotecan Plus Cisplatin versus Etoposide Plus Cisplatin in Chemotherapy-Naïve Korean Patients with Extensive-Disease Small Cell Lung Cancer

A Meta-Analysis of Randomized Controlled Trials Comparing Irinotecan/Platinum with Etoposide/Platinum in Patients with Previously Untreated Extensive-Stage Small Cell Lung Cancer

Liposomal Irinotecan Achieves Significant Survival and Tumor Burden Control in a Triple Negative Breast Cancer Model of Spontaneous Metastasis

Contact Info

Product

Resources

About