Cieľ Adjuvantná chemoterapia založená na cisplatine (adjuvant cisplatin-based chemotherapy, ACT) je v súčasnosti akceptovaným štandardom pre kompletne resekované štádium II a III nemalobunko- vého karcinómu pľúc (non–small-cell lung cancer, NSCLC). Dôležité je dlhodobé sledovanie, aby sa dokumentoval pretrvávajúci úžitok a neskorá toxicita. V tejto publikácii podávame správu o aktuali- zovaných údajoch celkového prežitia (overall survival, OS) a prežitia špecificky súvisiaceho s ocho- rením (disease-specific survival, DSS). Pacienti a metódy Pacienti s kompletne resekovaným NSCLC štádia Ib (T2N0, n = 219) alebo II (T1-2N1, n = 263) boli randomizovaní na 4 cykly vinorelbín/cisplatina alebo na observáciu. Všetky analýzy efektivity boli vykonané na báze zámeru vyliečenia pacientov. Výsledky Medián sledovania pacientov bol 9,3 roka (rozmedzie od 5,8 do 13,8; zo sledovania sa 33 pacien- tov stratilo). Celkove 271 pacientov zo 482 randomizovaných pacientov zomrelo. ACT sústavne vykazuje prospešnosť (pomer rizík [hazard ratio, HR] = 0,78; 95% interval spoľahlivosti [confi- dence interval, CI] 0,61–0,99; p = 0,04). Bol prítomný trend k interakcii so štádiom ochorenia (p = 0,09; HR pre štádium II = 0,68; 95% CI 0,5–0,92; p = 0,01; štádium IB, HR = 1,03; 95% CI, 0,7–1,52; p = 0,87). Výsledkom ACT bolo signifikantné predĺženie DSS (HR = 0,73; 95% CI 0,55–0,97; p = 0,03). Observácia bola spojená so signifikantne vyšším rizikom úmrtia na karcinóm pľúc (p = 0,02). Medzi oboma ramenami nebol rozdiel v miere úmrtia z inej príčiny alebo z dôvodu druhého malígneho ochorenia. Záver Predĺžené sledovanie pacientov zo štúdie JBR.10 pokračuje vo vykazovaní úžitku v prežití pre rameno s adjuvantnou chemoterapiou. Ukazuje sa, že tento úžitok sa viaže na pacientov s N1. V ramene s chemoterapiou nebol pozorovaný žiadny nárast úmrtnosti z inej príčiny.

Adjuvant cisplatin-based chemotherapy (ACT) is now an accepted standard for completely resected stage II and III A non-small-cell lung cancer (NSCLC). Long-term follow-up is important to document persistent benefit and late toxicity. We report here updated overall survival (OS) and disease-specific survival (DSS) data. PATIENTS AND METHODS Patients with completely resected stage IB (T2N0, n = 219) or II (T1-2N1, n = 263) NSCLC were randomly assigned to receive 4 cycles of vinorelbine/cisplatin or observation. All efficacy analyses were performed on an intention-to-treat basis. Results Median follow-up was 9.3 years (range, 5.8 to 13.8; 33 lost to follow-up); there were 271 deaths in 482 randomly assigned patients. ACT continues to show a benefit (hazard ratio [HR], 0.78; 95% CI, 0.61 to 0.99; P = .04). There was a trend for interaction with disease stage (P = .09; HR for stage II, 0.68; 95% CI, 0.5 to 0.92; P = .01; stage IB, HR, 1.03; 95% CI, 0.7 to 1.52; P = .87). ACT resulted in significantly prolonged DSS (HR, 0.73; 95% CI, 0.55 to 0.97; P = .03). Observation was associated with significantly higher risk of death from lung cancer (P = .02), with no difference in rates of death from other causes or second primary malignancies between the arms. CONCLUSION Prolonged follow-up of patients from the JBR.10 trial continues to show a benefit in survival for adjuvant chemotherapy. This benefit appears to be confined to N1 patients. There was no increase in death from other causes in the chemotherapy arm.

• MeSH
• Cisplatin MeSH
• Adult MeSH
• Financing, Organized MeSH
• Genes, ras MeSH
• Middle Aged MeSH
• Humans MeSH
• Mutation MeSH
• Lung Neoplasms drug therapy   mortality   pathology   MeSH
• Carcinoma, Non-Small-Cell Lung drug therapy   mortality   pathology   MeSH
• Antineoplastic Combined Chemotherapy Protocols therapeutic use   MeSH
• Randomized Controlled Trials as Topic MeSH
• Neoplasms, Second Primary etiology   MeSH
• Aged MeSH
• Neoplasm Staging MeSH
• Vinblastine analogs & derivatives   MeSH
• Check Tag
• Adult MeSH
• Middle Aged MeSH
• Humans MeSH
• Male MeSH
• Aged MeSH
• Female MeSH
• Publication type
• Clinical Trial, Phase III MeSH
• Comparative Study MeSH