Objetivo: A quimioterapia adjuvante melhora a sobrevida de pacientes com câncer pulmonar de células não pequenas (CPCNP) ressecado. No entanto, o esquema cisplatina-vinorelbina está relacionado com risco significativo de toxicidade clinicamente relevante. Nosso objetivo foi avaliar a eficácia, segurança e viabilidade da quimioterapia adjuvante para pacientes com CPCNP em um cenário de mundo real. Métodos: Estudo retrospectivo de coorte realizado em um único centro com pacientes com CPCNP em estágio I-III submetidos a cirurgia com intuito curativo entre 2009 e 2018. A quimioterapia adjuvante foi administrada a critério dos médicos. Os pacientes foram divididos em dois grupos: quimioterapia adjuvante e sem quimioterapia adjuvante (grupo controle). Os desfechos estudados foram sobrevida global (SG) e sobrevida livre de recidiva (SLR), bem como o perfil de segurança e viabilidade do esquema cisplatina-vinorelbina em um cenário de mundo real. Resultados: O estudo envolveu 231 pacientes, 80 dos quais receberam quimioterapia adjuvante. Destes, 55 receberam o esquema cisplatina-vinorelbina. As análises de sobrevida estratificadas pelo estágio do tumor mostraram que os pacientes com CPCNP em estágio II que receberam quimioterapia adjuvante apresentaram melhor SLR (p = 0,036) e SG (p = 0,017) do que os do grupo controle. Entre os pacientes com CPCNP em estágio III que receberam quimioterapia adjuvante, a SLR foi melhor (p < 0,001) e houve uma tendência a melhor SG do que no grupo controle (p = 0,060). Dos que receberam o esquema cisplatina-vinorelbina, 29% apresentaram neutropenia febril de grau 3-4, e 9% morreram em virtude de toxicidade. Conclusões: Os resultados confirmam o efeito benéfico da quimioterapia adjuvante em pacientes com CPCNP em um contexto real. No entanto, o esquema cisplatina-vinorelbina relacionou-se com taxas alarmantes de toxicidade e alternativas mais eficazes e menos tóxicas devem ser investigadas.

Background: Platinum-based adjuvant chemotherapy (CT) improves survival in surgically resected non-small-cell lung cancer (NSCLC) patients (pts). However, cisplatin and vinorelbine (PV), the most studied regimen, is often associated with increased rates of grade 3-4 toxicities. We aimed to study the efficacy and safety of adjuvant CT in NSCLC pts in a real-world scenario. Methods: We performed a retrospective analysis of NSCLC pts treated with surgery with curative intent between 2009 and 2018 in an academic cancer center. After surgery, pts were accessed to receive adjuvant CT, based on physicians' discretion. Electronic records were reviewed and data were collected for pts and tumor characteristics, treatments, outcomes (overall survival [OS] and disease-free survival [DFS]), and toxicities. OS and DFS were estimated by the Kaplan-Meier method, and curves were compared by log-rank. Prognostic factors were evaluated using Cox regression. Results: 250 consecutive pts were studied: 80 adjuvant CT and 170 observation; 55/80 received PV. Median age 65 years, 62% adenocarcinoma and 28% squamous cell carcinoma. The observation group differed from the adjuvant CT group in terms of type of surgery (lobectomy, 88% vs 76%; p ¼ .020), 7 th ed TNM staging (I, 50% vs 2%; II, 29% vs 45%; III, 20% vs 42%; p < .001), and lymph node status (N0, 71% vs 31%; p < .001). After a median follow-up of 24 months (mo), median DFS was 56.0 vs 39.3 mo in CT and observation groups, and median OS was 61.4 vs 58.5 mo, respectively. In an adjusted analysis, adjuvant CT was associated with improved DFS (HR 0.36, IC 95% 0.23-0.58; p < .001) and OS (HR 0.47, IC 95% 0.28-0.78; p .004). Toxicities were high in the PV group: 49% of the pts required hospitalization, 45% discontinued treatment, and 89% presented grade 3-4 toxicities, including 29% of febrile neutropenia. Five pts (9%) had treatment-related deaths. Conclusions: Our study supports both the OS and DFS benefits of NSCLC adjuvant CT in the real world scenario. However, PV was associated with alarming rates of treatment-related toxicities and deaths, suggesting that new adjuvant avenues are warranted.Legal entity responsible for the study: The authors. Funding: Has not received any funding. Disclosure: All authors have declared no conflicts of interest.100P A new PET-CT score for locally-advanced inoperable NSCLC stage III patients treated with chemoradiotherapy