title: A phase II study of induction chemotherapy followed by concurrent chemoradiotherapy in elderly patients with locally advanced non-small-cell lung cancer.
abstract: The optimal management of unresectable locally advanced non-small-cell lung cancer in older patients has not been defined to date. The present phase II study was planned to evaluate the activity and safety of platinum-based induction chemotherapy followed by concurrent chemoradiotherapy in elderly patients with locally advanced non-small-cell lung cancer. Patients received two cycles of paclitaxel (175 mg/m) and carboplatin (area under the curve: 5) day 1, every 3 weeks. Chemoradiotherapy (thoracic radiation therapy) was initiated on day 42 and consisted of 1.8 Gy daily, five times per week over 5 weeks (45.0 Gy target dose) followed by 10 2.0 Gy daily fractions. Concomitant chemotherapy was weekly paclitaxel 50 mg/mq followed by weekly carboplatin at an area under the curve of 2. The eligibility for patients: age 70 or older and histologically documented untreated non-small-cell lung cancer, locally advanced, unresectable, stage III A N2 bulky or III B. Thirty consecutive patients were enrolled onto the study. The median age was 73 (range 70-76). According to the intention-to-treat analysis, 1 month after the end of combined chemoradiotherapy, we observed complete and partial responses in one and 19 of the 30 patients, respectively, for an overall response rate of 66% (95% confidence interval, 45-76%). Median progression-free survival was 8.7 months (95% confidence interval, 3.4-37.8) and median survival was 15 months (95% confidence interval, 4.2-52.1). During the treatment, 12 patients (40.0%) experienced grade 3-4 neutropenia, two patients neutropenic fever, and three patients grade 3 anaemia and grade 3 thrombocytopenia, respectively. Grade 3 oesophagitis, during concomitant radiotherapy, was observed in six patients (20.0%). No treatment-related mortality was reported. The investigated sequential approach including induction chemotherapy followed by concurrent chemoradiotherapy appears safe and seems a reasonable chance for the treatment of locally advanced non-small-cell lung cancer in the elderly population.
authors.affiliation: Gravina Hospital, Oncology Unit, Caltagirone, Italy.
authors.forename: Carmelo G
authors.initials: CG
authors.lastname: Giorgio
authors.forename: Alessandro
authors.initials: A
authors.lastname: Pappalardo
authors.forename: Antonio
authors.initials: A
authors.lastname: Russo
authors.forename: Daniele
authors.initials: D
authors.lastname: Santini
authors.forename: Carlo
authors.initials: C
authors.lastname: Di Rosa
authors.forename: Carmela
authors.initials: C
authors.lastname: Di Salvo
authors.forename: Sergio
authors.initials: S
authors.lastname: Castorina
authors.forename: Franco
authors.initials: F
authors.lastname: Marletta
authors.forename: Giuseppe
authors.initials: G
authors.lastname: Bellissima
authors.forename: Nuccio
authors.initials: N
authors.lastname: Palermo
authors.forename: Concetto
authors.initials: C
authors.lastname: Scuderi
authors.forename: Roberto
authors.initials: R
authors.lastname: Bordonaro
mesh_terms: D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy* / Q000473:pathology / Q000532:radiotherapy*; D003131:Combined Modality Therapy; D018572:Disease-Free Survival; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D008175:Lung Neoplasms / Q000188:drug therapy* / Q000473:pathology / Q000532:radiotherapy*; D008297:Male; D020360:Neoadjuvant Therapy; D009367:Neoplasm Staging