The rationale for the NEOCOR study: A new paradigm in locally advanced non-small cell lung cancer
17146 Background: Most patients with locally advanced NSCLC die of systemic disease. (Chevalier et al JNCI 1991). Concurrent chemoRT + adjuvant chemotherapy is the standard of care based on a metaanalysis comparing sequential chemoRT and Concurrent chemoRT, with median survival increased by 3 months. (Hak Choy ASCO 2003) The aim is to critically review all the sequential trials and the metaanalysis against a scientifically valid criteria. Methods: A scientifically valid trial comparing the two approaches: sequential chemoRT versus Concurrent chemoRT needs to have equivalent chemotherapy in both arms. It also needs to have equivalent chemoRT in both arms. There needs to be an adequate course of neoadjuvant chemotherapy (at least 4 cycles) in the sequential chemoRT arm. All the relevant sequential chemoRT versus concurrent chemoRT trials are critically reviewed. Results: The sequential chemoRT trials had an average of 2 cycles of chemotherapy before radiation. (Dillman et al CALGB B 8433, Sause et al ECOG 4588, Schaakee - Koning et al NEJM 1992). The Hak Choy metaanalysis is not a comparison of the two approaches: sequential chemoRT versus concurrent chemoRT. The WJLCG Furuse trial had more intensive chemotherapy in the concurrent arm. The GLOT-GFPC study had Etoposide chemotherapy on the concurrent arm. The LAMP study, Zatloukal - Zemanova study & RTOG 9410 all had 2 cycles of chemotherapy followed by radiotherapy or concurrent chemoRT. SWOG 9504 using Cisplatin + Etoposide concurrent with Radiotherapy and adjuvant Docetaxel suggests that systemic treatment is important along with concurrent chemoRT. Betticher et al ( JCO 2003) showed that neoadjuvant chemotherapy with Docetaxel + Cisplatin achieves a 19% complete pathological response & overall 66% response rate. Conclusions: Most patients with locally advanced NSCLC still die of systemic disease. Sequential chemoRT trials did not have adequately intensive chemotherapy regimens.Concurrent ChemoRT is a better form of RT. The author proposes a phase II trial of Neoadjuvant Chemotherapy with 4 cycles of Docetaxel 85 mg/m2 D1+ Cisplatin 50 mg/m2 D1 & 2 followed by 2 cycles of Concurrrent Chemoradiotherapy with Cisplatin 50 mg/m2 D1 & D8 + Etoposide 50 mg/m2 D1–5 concurrent with 61 Gy of Radiotherapy as a new paradigm in Locally advanced NSCLC. No significant financial relationships to disclose.