Chemotherapy With or Without Maintenance Sunitinib for Untreated Extensive-Stage Small-Cell Lung Cancer: A Randomized, Double-Blind, Placebo-Controlled Phase II Study—CALGB 30504 (Alliance)

Ready, Neal; Pang, Herbert; Gu, Lin; Otterson, Gregory A.; Thomas, Sachdev; Miller, Antonius A.; Baggstrom, Maria Q.; Masters, Gregory A.; Graziano, Stephen L.; Crawford, Jeffrey; Bogart, Jeffrey A.; Vokes, Everett E.

doi:10.1200/jco.2014.57.3105

Cited by 118 publications

(94 citation statements)

References 27 publications

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“…The survival results obtained in this trial are consistent with those of prior studies performed using anti-angiogenic agents in SCLC (3,4). For example, these data are similar to those obtained in the SALUTE phase II trial, that randomized 102 patients to the same regimens; this study met its primary end-point of improvement in PFS (from 4.4 to 5.5 months; HR: 0.53; 95% CI, 0.32 to 0.86), but similarly no statistically significant benefit in OS was observed (3).…”

supporting

confidence: 87%

Is the door open to further investigation with antiangiogenesis in SCLC?

Tiseo¹,

Boni

Ardizzoni

2018

J. Thorac. Dis.

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supporting

confidence: 87%

Is the door open to further investigation with antiangiogenesis in SCLC?

Tiseo¹,

Boni

Ardizzoni

2018

J. Thorac. Dis.

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“…Despite the benefits of TRT in ES-SCLC, long-term outcomes remain poor, and further progress is needed both in systemic therapy and radiotherapy to improve patient survival, and targeted agents may hold promise [23]. …”

Section: Page 16mentioning

confidence: 99%

Thoracic Radiotherapy for Extensive Stage Small-Cell Lung Cancer: A Meta-Analysis

Palma

Warner

Louie

et al. 2016

Clinical Lung Cancer

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“…The methods of CALGB 30504 have been published [5]. Briefly, each participant signed an IRB-approved, protocol-specific informed consent in accordance with federal and institutional guidelines.…”

Section: Methodsmentioning

confidence: 99%

Positive Interaction between Prophylactic Cranial Irradiation and Maintenance Sunitinib for Untreated Extensive-Stage Small Cell Lung Cancer Patients After Standard Chemotherapy: A Secondary Analysis of CALGB 30504 (ALLIANCE)

Salama

Wang

et al. 2016

Journal of Thoracic Oncology

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Background Prophylactic cranial irradiation (PCI) has become a standard option for extensive stage small cell lung cancer (ES-SCLC) patients. CALGB 30504 was a randomized phase II study of sunitinib vs placebo in ES-SCLC patients responding to platinum-based therapy requiring pre-enrollment brain imaging. PCI was at the discretion of treating physicians. We performed a secondary analysis of CALGB 30504 to determine the impact of PCI on ES-SCLC patients. Methods Fisher’s exact and Wilcoxon rank-sum tests were conducted to test the differences between PCI and non-PCI patients. Kaplan-Meier analyses described PFS and OS for PCI and non-PCI patients. Results 85 patients received maintenance (41 placebo, 44 sunitinib). 41 received PCI, 44 did not. Characteristics were balanced between PCI and no-PCI patients. PCI patients receiving sunitinib had non-significant 2.7-month PFS improvement (5.0 months vs. 2.3 months, p=0.14, HR=0.62 (95% CI: 0.33–1.18)), trending toward improved OS (8.9 months vs. 5.4 months, p=0.053, HR: 0.47 (0.22–1.03)). PCI was associated with a trend toward improved median PFS (2.9 months vs. 2.2 months, p=0.096, HR=0.69 (95% CI 0.45–1.07)), but not median OS (PCI 8.3 months vs. no PCI 8.7 months, p=0.76, HR=1.07 (95% CI 0.67–1.71)). Placebo patients had no PFS or OS difference. Conclusions Trends for improved PFS and OS were seen in patients receiving PCI and sunitinib supporting the need for further prospective research evaluating the integration of maintenance systemic therapy and PCI in ES-SCLC. Improved outcomes for ES-SCLC patients after induction chemotherapy may require PCI and systemic therapy to achieve control of both intracranial and extracranial disease.

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Chemotherapy With or Without Maintenance Sunitinib for Untreated Extensive-Stage Small-Cell Lung Cancer: A Randomized, Double-Blind, Placebo-Controlled Phase II Study—CALGB 30504 (Alliance)

Abstract: Maintenance sunitinib was safe and improved PFS in extensive-stage SCLC.

Cited by 118 publications

References 27 publications

Is the door open to further investigation with antiangiogenesis in SCLC?

Is the door open to further investigation with antiangiogenesis in SCLC?

Thoracic Radiotherapy for Extensive Stage Small-Cell Lung Cancer: A Meta-Analysis

Positive Interaction between Prophylactic Cranial Irradiation and Maintenance Sunitinib for Untreated Extensive-Stage Small Cell Lung Cancer Patients After Standard Chemotherapy: A Secondary Analysis of CALGB 30504 (ALLIANCE)

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