Survival study of neoadjuvant versus adjuvant chemotherapy with docetaxel combined carboplatin in resectable stage IB to IIIA non-small lung cancer.

Authors

Xue-ning Yang

Xue-Ning Yang

Guangdong Lung Cancer Institute, Guangdong General Hospital and Guangdong Academy of Medical Sciences, Guangzhou, China

Xue-Ning Yang , Gang Cheng , Xiao-song Ben , Hong-He Luo , Chang-li Wang , Wenzhao Zhong , Di Ge , Gui-bin Qiao , Zheng Wang , Yang Shentu , Jie Yang , Hong hong Yan , Yi Long Wu

Organizations

Guangdong Lung Cancer Institute, Guangdong General Hospital and Guangdong Academy of Medical Sciences, Guangzhou, China, Guangdong General Hospital and Guangdong Academy of Medical Sciences, Guangzhou, China, Department of Thoracic Surgery,The First Affiliated Hospital of SUN Yat-sen University, Guangzhou, China, Tianjin Medical University Cancer Institute and Hospital, Tianjin, China, Department of Thoracic Surgery, Zhongshan Hospital of Fudan University, Shanghai, China, Department of Chest Surgery,General Hospital of Guangzhou Military Command, Guangzhou, China, Shenzhen People’s Hospital, Shenzhen, China, Shandong Provincial Chest Hospital; Shanghai Lung Tumor Clinical Medical Center, Shanghai, China, Department of Thoracic Surgery,The First People s Hospital of Foshan, Foshan, China, Guangdong Lung Cancer Institute, Guangdong General Hospital, Guangzhou, China

Research Funding

Other Foundation

Background: Adjuvant chemotherapy is the standard of care for completely resected stage 2-3 non-small cell lung cancer(NSCLC). A few trials suggest neoadjuvant chemotherapy is a promising mode for resectable NSCLC. Indirect comparison meta-analysis of adjuvant versus neoadjuvant therapy showed no difference in survival. This study was conducted to determine whether neoadjuvant chemotherapy or adjuvant chemotherapy prolongs disease-free survival among patients with resectable NSCLC. Methods: Patients with clinical stage IB-IIIA NSCLC were eligible. Patients were randomly assigned to 3 cycles of neoadjuvant DC (Docetaxel: 75mg/m2, Carboplatin :AUC=5 on day 1 every 3wk),followed by surgery 3-6 wk after chemotherapy, or surgery followed by 3 cycles of adjuvant DC at the same schedule. The primary end point was 3 years Disease Free Survival(DFS); secondary end points were 3 years Overall Survival rate (OS) and Safety. Planned sample size is 410. Results: Between March 2006 and May 2011, 198 patients have been accrued, 97 in the neoadjuvant arm, 101 in the adjuvant arm. The neoadjuvant arm had more patients received chemotherapy( 100% v.s 85.1%, P<0.001 ) and received 3 cycles( 91.8% v.s82.6%, P=0.061) than adjuvant arm. Both arms are well tolerated to DC chemotherapy. The most common grade 3/4 adverse event is neutropenia (41.2% with neoadjuvant arm v.s 31.7% with adjuvant arm). One chemotherapy related death in adjuvant arm. One patient die of perioperative pulmonary embolism in neoadjuvant arm. No difference in peri-operative complication between two arms. The 3 years DFS was 45% in the neoadjuvant arm and 53% in the adjuvant arm, HR=0.88 (0.58-1.33), P=0.54. Median survival has not been reached in both arms. Conclusions: Neoadjuvant or adjuvant chemotherapy with docetaxel plus carboplatin in resectable clinical stage IB-IIIA NSCLC is feasible and safe. Preliminary results show similar 3 years DFS in both arms. The OS data has not matured in both arms. Clinical trial information: NCT00321334.

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Abstract Details

Meeting

2013 ASCO Annual Meeting

Session Type

Poster Session

Session Title

Lung Cancer - Non-small Cell Local-regional/Small Cell/Other Thoracic Cancers

Track

Lung Cancer

Sub Track

Adjuvant Therapy

Clinical Trial Registration Number

NCT00321334

Citation

J Clin Oncol 31, 2013 (suppl; abstr 7537)

DOI

10.1200/jco.2013.31.15_suppl.7537

Abstract #

7537

Poster Bd #

19G

Abstract Disclosures