Multinational Randomized Phase III Trial With or Without Consolidation Chemotherapy Using Docetaxel and Cisplatin After Concurrent Chemoradiation in Inoperable Stage III Non–Small-Cell Lung Cancer: KCSG-LU05-04

Ahn, Jin Seok; Ahn, Yong Chan; Kim, Joo Hang; Lee, Chang Geol; Cho, Eun Kyung; Lee, Kyu Chan; Chen, Ming; Kim, Dong Wan; Kim, Hoon Kyo; Min, Young Joo; Kang, Jin Hyoung; Choi, Jin Hyuck; Kim, Sang We; Zhu, Guangying; Wu, Yi‐Long; Kim, Sung Rok; Lee, Kyung Hee; Song, Hong Suk; Choi, Yoon La; Sun, Jong Mu; Jung, Sin Ho; Ahn, Myung Ju; Park, Keunchil

doi:10.1200/jco.2014.60.0130

Cited by 228 publications

(145 citation statements)

References 38 publications

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“…Furthermore, we need to consider surgical extirpation in patients with residual disease after standard CCRT using 60 Gy if further dose escalation does not provide a survival advantage. Induction or consolidation chemotherapy or maintenance therapy [9-11] failed to show a survival gain in combination with CCRT. Thus, the proven benefit of immunotherapy in stage IV lung cancer warrants its evaluation for use in earlier stages of lung cancer.…”

Section: Introductionmentioning

confidence: 99%

Multidisciplinary team approach for the management of patients with locally advanced non-small cell lung cancer: searching the evidence to guide the decision

Ahn

2017

Radiat Oncol J

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Locally advanced non-small cell lung cancer (LA-NSCLC) is composed of heterogeneous subgroups that require a multidisciplinary team approach in order to ensure optimal therapy for each patient. Since 2010, the National Comprehensive Cancer Network has recommended chemoradiation therapy (CRT) for bulky mediastinal disease and surgical combination for those patients with single-station N2 involvement who respond to neoadjuvant therapy. According to lung cancer tumor boards, thoracic surgeons make a decision on the resectability of the tumor, if it is determined to be unresectable, concurrent CRT (CCRT) is considered the next choice. However, the survival benefit of CCRT over sequential CRT or radiotherapy alone carries the risk of additional toxicity. Considering severe adverse events that may lead to death, fit patients who are able to tolerate CCRT must be identified by multidisciplinary tumor board. Decelerated approaches, such as sequential CRT or high-dose radiation alone may be a valuable alternative for patients who are not eligible for CCRT. As a new treatment strategy, investigators are interested in the application of the innovative radiation techniques, trimodality therapy combining surgery after high-dose definitive CCRT, and the combination of radiation with targeted or immunotherapy agents. The updated results and on-going studies are thoroughly reviewed in this article.

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Section: Introductionmentioning

confidence: 99%

Multidisciplinary team approach for the management of patients with locally advanced non-small cell lung cancer: searching the evidence to guide the decision

Ahn

2017

Radiat Oncol J

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“…1 There is no survival advantage for consolidative docetaxel/cisplatin after definitive chemoradiation compared to chemoradiation alone. 2 In unselected patients with stage 3 NSCLC, the addition of the epidermal growth factor receptor inhibitor gefitinib as maintenance therapy after completion of cisplatin-based concurrent chemoradiation demonstrates a decrease in survival. 3 Adding the anti-EGFR monoclonal antibody cetuximab to chemoradiation does not extend survival.…”

Section: Study Rationalementioning

confidence: 99%

Treatment Design and Rationale for a Randomized Trial of Cisplatin and Etoposide Plus Thoracic Radiotherapy Followed by Nivolumab or Placebo for Locally Advanced Non–Small-Cell Lung Cancer (RTOG 3505)

Gerber

Urbanic

Langer

et al. 2017

Clinical Lung Cancer

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RTOG 3505 is a randomized phase 3 study of concurrent chemoradiation followed by immune checkpoint inhibitor therapy or placebo in patients with locally advanced non-small cell lung cancer (NSCLC). Patients with surgically unresectable stage 3 NSCLC will receive thoracic radiation therapy (RT) to 60 Gy with concurrent cisplatin 50 mg/m2 IV on Days 1, 8, 29, and 36, and etoposide 50 mg/m2 IV on Days 1–5 and 29–33. Between 4 and 12 weeks after completion of concurrent chemoradiation, eligible patients will be randomized to the anti-programmed death 1 (PD1) monoclonal antibody nivolumab 240 mg IV or placebo every 2 weeks for up to 1 year. Co-primary endpoints are overall survival (OS) and progression-free survival (PFS), as determined by central independent radiology review. Secondary objectives include toxicity assessment, patient-reported outcomes and quality of life, and OS and PFS in PD-L1-expressors (≥1%) and PD-L1-non-expressors (<1%). Assuming a rate of 16.7% due to ineligibility and drop-out before randomization, a total of 660 patients will be enrolled to ensure 550 patients will be randomized after completion of chemoradiation. This sample size will provide ≥90% power to detect (1) a hazard ratio (HR) of 0.7 for OS with two-sided type I error of 0.04, and (2) HR of 0.667 for PFS two-sided type I error of 0.01. NCT02768558

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“…At a median follow-up of 50.7 months, there was no significant difference ( P = .438) in median OS between the observation arm (20.63 months) and the consolidative chemotherapy arm (21.78 months). 11 …”

Section: Kcsgmentioning

confidence: 99%

Overview of Thoracic Oncology Trials in Cooperative Groups Around the Globe

Salahudeen

Patel

Baas

et al. 2017

Clinical Lung Cancer

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Survival rates of patients with either early and advanced stage non–small-cell lung cancer (NSCLC) have improved with newer systemic therapy and radiation techniques, including combination regimens, targeted therapies, and immunotherapies. The cancer cooperative groups have historically played a critical role in the advancement of NSCLC therapy. Annually, representatives from cooperative groups worldwide convene at the International Lung Cancer Congress (ILCC). In summer 2015, the ILCC reached its 16th anniversary. This article highlights the NSCLC studies presented by participating groups in 2015.

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Multinational Randomized Phase III Trial With or Without Consolidation Chemotherapy Using Docetaxel and Cisplatin After Concurrent Chemoradiation in Inoperable Stage III Non–Small-Cell Lung Cancer: KCSG-LU05-04

Abstract: CC with DP after CCRT with weekly DP in LA-NSCLC failed to further prolong PFS. CCRT alone should remain the standard of care.

Cited by 228 publications

References 38 publications

Multidisciplinary team approach for the management of patients with locally advanced non-small cell lung cancer: searching the evidence to guide the decision

Multidisciplinary team approach for the management of patients with locally advanced non-small cell lung cancer: searching the evidence to guide the decision

Treatment Design and Rationale for a Randomized Trial of Cisplatin and Etoposide Plus Thoracic Radiotherapy Followed by Nivolumab or Placebo for Locally Advanced Non–Small-Cell Lung Cancer (RTOG 3505)

Overview of Thoracic Oncology Trials in Cooperative Groups Around the Globe

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