TY - JOUR
T1 - Positive interaction between prophylactic cranial irradiation and maintenance sunitinib for untreated extensive-stage small cell lung cancer patients after standard chemotherapy
T2 - A secondary analysis of CALGB 30504 (ALLIANCE)
AU - Salama, Joseph K.
AU - Gu, Lin
AU - Wang, Xiaofei
AU - Pang, Herbert H.
AU - Bogart, Jeffrey A.
AU - Crawford, Jeffrey
AU - Schild, Steven E.
AU - Vokes, Everett E.
AU - Ready, Neal E.
N1 - Funding Information:
The research reported in this publication was supported by the National Cancer Institute, National Institutes of Health, under the award numbers U10CA180821 and U10CA180882 (to the Alliance for Clinical Trials in Oncology). The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.
Funding Information:
The research reported in this publication was supported by the National Cancer Institute , National Institutes of Health , under the award numbers U10CA180821 and U10CA180882 (to the Alliance for Clinical Trials in Oncology). The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.
Publisher Copyright:
© 2015 International Association for the Study of Lung Cancer. Published by Elsevier Inc. All rights reserved.
PY - 2016/3/23
Y1 - 2016/3/23
N2 - Background: Prophylactic cranial irradiation (PCI) has become a standard option for patients with extensive-stage small cell lung cancer (ES-SCLC). The Cancer and Leukemia Group B 30504 trial was a randomized phase II study of the effect of sunitinib versus placebo in ES-SCLC patients responding to platinum-based systemic therapy. The study required preenrollment brain imaging. PCI was provided at the discretion of treating physicians. We performed a secondary analysis of the Cancer and Leukemia Group B trial to determine the impact of PCI on patients with ES-SCLC. Methods: Fisher's exact test and the Wilcoxon rank-sum test were conducted to identify the differences between patients receiving PCI and patients not receiving PCI. Kaplan-Meier analyses described progression-free survival (PFS) and overall survival (OS) for patients in the PCI and non-PCI groups. Results: A total of 85 patients received maintenance therapy (41 received placebo and 44 received sunitinib). Patient characteristics were balanced between the PCI and non-PCI groups. The patients receiving PCI plus sunitinib had a nonsignificant 2.7-month improvement in PFS (5.0 months versus 2.3 months, p = 0.14, hazard risk [HR] = 0.62, 95% confidence interval [CI]: 0.33-1.18) trending toward improved OS (8.9 months versus 5.4 months, p = 0.053, HR = 0.47, 95% CI: 0.22-1.03). PCI was associated with a trend toward improved median PFS (2.9 months versus 2.2 months, p = 0.096, HR = 0.69, 95% CI: 0.45-1.07) but not median OS (8.3 months in the PCI group versus 8.7 months in the non-PCI group, p = 0.76, HR = 1.07, 95% CI: 0.67- 1.71). The patients receiving placebo had no improvement in PFS or OS with PCI. Conclusions: Trends toward improved PFS and OS were seen in patients receiving PCI and sunitinib, thus supporting the need for further prospective research evaluating the integration of maintenance systemic therapy and PCI for patients with ES-SCLC. Improved outcomes for patients with ES-SCLC after induction chemotherapy may require PCI, thoracic radiotherapy, and maintenance systemic therapy to achieve control of both intracranial and extracranial disease.
AB - Background: Prophylactic cranial irradiation (PCI) has become a standard option for patients with extensive-stage small cell lung cancer (ES-SCLC). The Cancer and Leukemia Group B 30504 trial was a randomized phase II study of the effect of sunitinib versus placebo in ES-SCLC patients responding to platinum-based systemic therapy. The study required preenrollment brain imaging. PCI was provided at the discretion of treating physicians. We performed a secondary analysis of the Cancer and Leukemia Group B trial to determine the impact of PCI on patients with ES-SCLC. Methods: Fisher's exact test and the Wilcoxon rank-sum test were conducted to identify the differences between patients receiving PCI and patients not receiving PCI. Kaplan-Meier analyses described progression-free survival (PFS) and overall survival (OS) for patients in the PCI and non-PCI groups. Results: A total of 85 patients received maintenance therapy (41 received placebo and 44 received sunitinib). Patient characteristics were balanced between the PCI and non-PCI groups. The patients receiving PCI plus sunitinib had a nonsignificant 2.7-month improvement in PFS (5.0 months versus 2.3 months, p = 0.14, hazard risk [HR] = 0.62, 95% confidence interval [CI]: 0.33-1.18) trending toward improved OS (8.9 months versus 5.4 months, p = 0.053, HR = 0.47, 95% CI: 0.22-1.03). PCI was associated with a trend toward improved median PFS (2.9 months versus 2.2 months, p = 0.096, HR = 0.69, 95% CI: 0.45-1.07) but not median OS (8.3 months in the PCI group versus 8.7 months in the non-PCI group, p = 0.76, HR = 1.07, 95% CI: 0.67- 1.71). The patients receiving placebo had no improvement in PFS or OS with PCI. Conclusions: Trends toward improved PFS and OS were seen in patients receiving PCI and sunitinib, thus supporting the need for further prospective research evaluating the integration of maintenance systemic therapy and PCI for patients with ES-SCLC. Improved outcomes for patients with ES-SCLC after induction chemotherapy may require PCI, thoracic radiotherapy, and maintenance systemic therapy to achieve control of both intracranial and extracranial disease.
KW - Extensive-stage small cell lung cancer
KW - Maintenance chemotherapy
KW - Prophylactic cranial irradiation
KW - Sunitinib
KW - Survival
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U2 - 10.1016/j.jtho.2015.11.001
DO - 10.1016/j.jtho.2015.11.001
M3 - Article
C2 - 26723241
AN - SCOPUS:84962551956
SN - 1556-0864
VL - 11
SP - 361
EP - 369
JO - Journal of Thoracic Oncology
JF - Journal of Thoracic Oncology
IS - 3
ER -