1333 - Erlotinib as frontline treatment for elderly patients (P) with advanced non-squamous non-small cell lung cancer (NSNSCLC): GGCP044/09 study

Date 28 September 2012
Event ESMO Congress 2012
Session Publication Only
Topics Anti-Cancer Agents & Biologic Therapy
Geriatric Oncology
Non-Small-Cell Lung Cancer, Metastatic
Presenter Jose Luis Firvida
Authors J.L. Firvida1, S. Vazquez2, J. Casal3, M. Alonso1, S. Varela2, M.J. Villanueva3, F.J. Afonso4, O. Fernandez1, C. Areses1, B. Campos2
  • 1Medical Oncology, Complexo Hospitario de Ourense, 32005 - Ourense/ES
  • 2Oncoloxia Médica, Hospital Universitario Lucus Augusti de Lugo, Lugo/ES
  • 3Medical Oncology, Complexo Hospitalario de Vigo, Vigo/ES
  • 4Medical Oncology, Complejo Hospitalario Arquitecto Marcide, Ferrol/ES

Abstract

Background

NSCLC is primarily a disease of older people with a median age of approximately 70 years (y) at diagnosis. Platinum combination chemotherapy (CT) has shown to be more effective than single agents but it is associated with more toxicity. Erlotinib is an EGFR TK inhibitor with a favourable toxicity profile and its oral administration makes it suitable to treat elderly p. No much is known about its efficacy and toxicities in this subpopulation, often under-represented in clinical trials. This Galician study aims to evaluate the efficacy and safety of erlotinib as 1st-line treatment (Tx) for elderly p with advanced nsNSCLC.

Material and methods

Elderly p (≥70 years old) with stage IIIB/IV nsNSCLC were included in this prospective observational study. Erlotinib was orally administered at a dose of 150 mg daily until disease progression or intolerable toxicity. PFS (primary objective) and OS were measured from time of diagnosis.

Results

A total of 31 p were enrolled. Baseline characteristics: Mean age 78 y (range 70-85); female 67.7%; adenocarcinoma (including BAC) 93.5%; never/current/former smokers (%): 54.8/16.1/22.6 (6.5% unknown), stage IV 84%; ECOG PS 0/1/2 (%): 6.4/45.2/48.4. The median PFS was 6.4 and the median OS was 9.9 months. Out of 26 evaluable p, 8 had PR and 8 SD, for an ORR of 30.8% and a DCR of 61.6%. The most common adverse event was skin rash, 38.7% (9.6% grade 3-4), diarrhoea, 25.8% (3.2% gr. 3-4) and asthenia, 19.3% (no gr 3-4 were reported). 5 p (16.1%) needed dose reduction and 3 p withdrew the Tx due to grade 3 diarrhoea, eye perforation and esofaghitis, respectively. EGFR mutational status was available for 10 p (32.2%); 4 p harboured activating mutations: 3 p achieved PR and 1 p SD. SLP of 31 (ongoing), 22.4 (ongoing), 13.6 and 9.8 months.

Conclusions

These results in real-life settings confirm that erlotinib is an active and well tolerated agent as frontline Tx in elderly p (≥70) in nsNSCLC. Response rate is similar to that achieved with CT in younger people; benefit in PFS is modest, but median OS is acceptable, taking into account that half of the p had a PS of 2. EGFR mutation testing should be strongly encouraged among elderly p.

Disclosure

All authors have declared no conflicts of interest.