1223P - Sex specific efficacy and safety outcomes in operable stage III non-small cell lung cancer (NSCLC): Pooled analysis of the SAKK trials 16/96, 16/00, 16/01, 16/08 and 16/14

Background

Current data is suggesting better survival in various cancer types but increased anticancer treatment toxicity in female compared to male patients (pts). Here, we report a pooled analysis of sex-related differences in survival outcomes and safety in pts with resectable stage III NSCLC treated in 5 prospective clinical trials.

Methods

Data from 499 pts included in five Swiss Group for Clinical Cancer Research (SAKK) trials for resectable stage III NSCLC (SAKK 16/96, 16/00, 16/01, 16/08, and 16/14) were pooled. All pts were treated with 3 cycles of chemotherapy (cisplatin/docetaxel). 207 (41%) pts received neoadjuvant chemotherapy, 229 (46%) neoadjuvant radiochemotherapy and 62 (12%) neoadjuvant chemotherapy and perioperative durvalumab.

Results

158 pts (31.7%) were females, median age was 60 years, 93% were ever-smokers, 64% had non-squamous NSCLC and 99% had ECOG 0-1. Females were more likely to be never-smokers and have non-squamous NSCLC (both p= <.0.001), otherwise baseline characteristics including age and stage were balanced. Median event-free survival (EFS) (24.4 vs. 11.8 months, p=0.014) and median overall survival (OS) (59.3 vs. 26.1 months, p=0.002) were significantly longer in female compared to male pts (5y-OS 49.2% vs. 36.6%). Both remained significant in a multivariable analysis correcting for age, smoking status, treatment modality and histology (EFS: HR 1.35, OS: 1.38). However, while the cause-specific hazard of non-cancer related death was increased in males (HR=2.14, 95% CI: 1.32-3.46, p=0.0019) the risk of tumor-related death was similar between sexes (HR=1.26, 95% CI: 0.96-1.65, p=0.09). No significant differences in the proportion of treatment related grade ≥ 3 adverse events (62.5% vs. 69.7%) or treatment discontinuation (3.2% vs 3.2%) were observed between females and males. However, the proportion of dose reductions was higher in females (32% vs 23%, p=0.037). Surgical outcomes (R0-resection rate and 30-day mortality) were similar between sexes.

Conclusions

EFS and OS were improved in female pts with an excess non-tumor related mortality seen in males. No significant differences in toxicity were observed.

Clinical trial identification

Editorial acknowledgement

Legal entity responsible for the study

L. Frehner.

Funding

Has not received any funding.

Disclosure

M. Guckenberger: Financial Interests, Institutional, Research Funding: Varian Siemens, AstraZeneca, ViewRay; Financial Interests, Personal and Institutional, Invited Speaker: AstraZeneca. M.T. Mark: Financial Interests, Institutional, Advisory Board: Janssen, Roche, Takeda, BMS, MSD, AstraZeneca, Merck; Financial Interests, Institutional, Research Grant: Gilead Science; Financial Interests, Institutional, Other, travel grant: Janssen, AstraZeneca, Roche, Takeda, Amgen. A. Addeo: Financial Interests, Personal and Institutional, Advisory Board: BMS, AstraZeneca, Boehringer Ingelheim, Roche, MSD, Pfizer, Eli Lilly, Astellas, Amgen, Novartis; Financial Interests, Personal and Institutional, Speaker’s Bureau: Eli Lilly, AstraZeneca, Amgen. S.I. Rothschild: Financial Interests, Institutional, Advisory Role: Amgen, AstraZeneca, Bayer, BMS, Boehringer Ingelheim, Eli Lilly, Janssen, Merck KG, MSD, Novartis, Otsuka, Pfizer, PharmaMar, Roche, Sanofi, Takeda; Financial Interests, Institutional, Financially compensated role: Roche, BMS, AstraZeneca, Amgen, MSD, Novartis, Roche; Financial Interests, Institutional, Other, travel support: Roche, Eli Lilly, BMS, Amgen, AstraZeneca, MSD. M. Pless: Financial Interests, Personal and Institutional, Advisory Board: AbbVie, Amgen, AstraZeneca, Bayer, BMS, Boehringer Ingelheim, Janssen, Merck, MSD, Nestle, Novartis, Pfizer, Roche, Sanofi, Takeda, Vifor. D. König: Financial Interests, Institutional, Advisory Role: AstraZeneca, MSD, Novartis; Financial Interests, Institutional, Invited Speaker: Amgen, Mirati, Sanofi, Roche, Oncology in Motion; Financial Interests, Institutional, Advisory Board: BMS, Merck, MSD, PharmaMar, AstraZeneca; Financial Interests, Institutional, Research Grant: Geistlich-Stucki Stifung. B.C. Özdemir: Financial Interests, Institutional, Advisory Board: BMS, MSD, Merck, Ipsen, Roche, Pfizer, Novartis, Janssen, Sanofi. S. Schmid: Financial Interests, Institutional, Research Grant: Janssen, MSD, von Tobel Stiftung, Swisslife, Marlies-Schwegler Stiftung; Financial Interests, Institutional, Advisory Board: BMS, MSD, Roche, Merck, Pfizer, Sanofi, Janssen, AstraZeneca, Takeda; Financial Interests, Personal, Other, Travel grant: Roche, Takeda, Amgen. All other authors have declared no conflicts of interest.