Journal of Clinical Oncology · 2011 · 17 citations · 0 references
MedicineOncologyRadiation OncologyChemotherapyClinical Radiation OncologyThoracic Radiation OncologyConcurrent ChemoradiationLung CancerLung Cancer PharmacotherapyMalignant NeoplasmsRadiation TherapyConcurrent Chemoradiation TherapyEpidermal Growth Factor Receptor InhibitionErlotinib TherapyNon-small Cell Lung Cancer TherapyNon-small Cell Lung Cancer TreatmentPhase Ii Clinical TrialsPhase Ii InvestigationTherapeutic Radiosensitization
7020 Background: Majority of non-small cell lung cancer (NSCLC) overexpress EGFR. Our prospective phase II trial investigated EGFR-TKI (erlotinib) as a radiosensitizer for inoperable stage III NSCLC patients (pts) who also received standard chemoradiotherapy (ChT/RT). Methods: 48 stage III NSCLC pts were enrolled from 3/2008 through 6/2010. ChT/RT was given every Monday followed by erlotinib/RT on Tuesday-Friday and erlotinib alone over the weekend. RT (63 Gy in 35 fractions) with weekly paclitaxel (45mg/m2)/carboplatin (AUC=2) and erlotinib (150 mg p.o. daily except on the day of chemotherapy) were given for 7 weeks. After one month break, pts received two cycles consolidation of paclitaxel (AUC=6) and carboplatin (200mg/m2). EGFR mutation analysis was performed for 41 pts. The response was evaluated by CT scan three months after completion of ChT/RT based on RECIST criteria. Fisher’s exact and Kaplan-Meier’s tests were used for the statistical analysis. Results: 46 pts completed the entire treatment are evaluable for response. All had PS KPS ≥80, 17 (37%) were female, 23 adenocarcinoma, and 87% former or current smokers, with median age 63 year-old (range: 46-81). Responses showed 14 (30%) CR, 23 (50%) PR and 9 (20%) stable or progressive disease. Five in 41 pts (12%) had EGFR mutation (EGFR-M), all adenocarcinoma with 2 females, compared to none of squamous histology (p=0.05). CR and non-CR were 3 and 2 in the EGFR-M group compared to 11 and 25 in the EGFR-wild group (p=0.32), respectively. The median OS and PFS were 25.8 mons & 13.6 mons, respectively. 1-year & 2-year OS were 84% & 75% and PFS 54% & 32%, respectively. Toxicity showed 2 grade 3 acne, 1 Grade 3 esophagitis, 3 Grade 3 pneumonitis and no Grade 4-5. Conclusions: This prospective phase II clinical study demonstrated an excellent 1-year OS 84 % and median OS 25.8 mons. All EGFR-M were seen in adenocarcinomas. Erlotinib demonstrated a radiosensitization effect.