125P - A prospective randomized phase III study of palliative chemotherapy versus best supportive care in elderly patients with advanced non-small cell lun...

Date 17 April 2015
Event ELCC 2015
Session Poster lunch
Topics Anti-Cancer Agents & Biologic Therapy
Supportive Care
Geriatric Oncology
Non-Small-Cell Lung Cancer, Metastatic
Palliative Care
Presenter Narender Kumar
Citation Annals of Oncology (2015) 26 (suppl_1): 29-44. 10.1093/annonc/mdv050
Authors N. Kumar1, A. Kapoor2, A. Kalwar3, S. Narayan2, M.K. Singhal2, A. Kumar4, S. Lal1, R.K. Nirban2, M. Paramanandhan2, R. Purohit2
  • 1Mbbs - Student, Sardar Patel Medical College, 334003 - Bikaner/IN
  • 2Radiation Oncology, Acharya Tulsi Regional Cancer Treatment & Research Institute, 334003 - Bikaner/IN
  • 3Oncology, MDM Group of Hospital, 342001 - Jodhpur/IN
  • 4Mbbs - Student, Medical College & SSG Hospital, 390001 - Vadodara/IN

Abstract

Aim/Background

Non-small cell lung cancer (NSCLC) is the leading cause of cancer mortality. At the time of diagnosis, most of the patients of NSCLC have advanced disease (stage IIIB or IV). Palliative chemotherapy and Best Supportive Care (BSC) are treatment options for these patients. Therapeutic response relies on the extension of disease and ECOG status of the patients. We did a non-blinded, randomized, phase III clinical trial to compare the BSC versus palliative chemotherapy in terms of overall survival (OS) and ECOG performance status regression analysis.

Methods

Newly diagnosed patients with stage IIIB/IV NSCLC from January 2002 to December 2010 were randomly assigned to platin (P) based doublet chemotherapy, geftinib or BSC alone. ECOG status of patients was assessed on every follow-up. The primary endpoint was the comparison of OS among therapies. Analysis was performed to observe the impact of therapy on OS by Kaplan-Meier survival and log rank tests, Cox proportional analysis using SPSS (20.0) (IBM, Armonk, NY). ECOG performance status regression analysis was performed by linear and quadratic regression models.

Results

1610 patients were enrolled (median age 67.2 years, males 91.78%, ECOG performance status 0/1, 2/3, 4: 11%, 34% and 55%, respectively). The median OS (95% CI) of 1610 patients was 9 (8.48-9.52) months. The median OS (95% CI) in months for BSC 15 (14.13-15.87), geftinib 12 (8.6-15.34), P + pemetrexed 12 (9.15-14.85), P + gemcitabine 9 (7.26-10.73), P + paclitaxel 9 (8.28-9.72) and P + etoposide 6 (5.35-6.64); (Chi-square = 358.5, P < 0.001). ECOG performance status regression with R2≥ 0.90 was analysed for all therapies. Geftinib follows linear quadratic model for all ECOG status. BSC follows polynomial quadratic regression model with power of two for all ECOG status. All other chemotherapies follow polynomial quadratic regression model with power of two for ECOG status 0/1 and with power of three for ECOG status 2/3 and 4.

Conclusions

BSC alone is a feasible option in elderly patients with advanced NSCLC. Geftinib is suitable in all ECOG status while other chemotherapeutic drugs fare better only in ECOG status 0/1.

Disclosure

All authors have declared no conflicts of interest.