A phase II single-arm study of induction chemotherapy with cisplatin and gemcitabine followed by concurrent cisplatin and gemcitabine with thoracic radiation for unresectable locally advanced non-small cell lung cancer

Abstract

Objectives: The aim of this study was to evaluate the efficacy and tolerability of the combination of cisplatin-gemcitabine with concurrent thoracic radiotherapy for locally advanced non-small cell lung cancer (LA-NSCLC). Methods: This was a phase II, multicenter, open-label, single-arm trial in treatment-naïve patients with stage IIIA and IIIB LA-NSCLC. After three induction cycles with gemcitabine 1250 mg/m 2 plus cisplatin 80 mg/m 2 , two concurrent chemoradiotherapy cycles with gemcitabine 300 mg/m 2 , cisplatin 80 mg/m 2 , and radiotherapy (63 Gy) were administered. The primary endpoint was response rate after induction chemotherapy followed by concurrent chemoradiotherapy. Secondary endpoints included time to progressive disease (TtPD), overall survival (OS), and safety. Results: Overall, 49 patients (median age 63.4 years; 73.5% male; Karnofsky performance status scores of 80, 85, 90, and 100 [16.3%, 2.0%, 49.0%, and 32.7%, respectively]; disease stage IIIA or IIIB 28.6% and 71.4%, respectively) were enrolled and treated. Response rate was 38.8% (95% confidence interval [CI] 25.2-53.8%). Median TtPD was 11.4 months (95% CI 9.4-12.9). Median OS was 21.8 months (95% CI 17.5-26.0), with 1-and 2-year survival rates of 70.8% and 43.7%, respectively. Overall, six patients discontinued from study treatment due to adverse events (AEs), of which two were serious AEs. The most relevant grade 3/4 AEs were neutropenia and thrombocytopenia in induction chemotherapy and chemoradiotherapy, and grade 3 events related to radiation in acute chemoradiotherapy, e.g. dysphagia, radiation pneumonitis, and radiation esophagitis. Conclusions: Induction chemotherapy followed by concurrent chemoradiotherapy with gemcitabine (300 mg/m 2 ) and cisplatin was associated with acceptable toxicity. The observed median OS time was 21.8 months. Response evaluation was difficult as in many cases it was not possible to differentiate tumor progression from local radiofibrosis.

Concurrent or Sequential Chemoradiotherapy after 3-4 Cycles Induction Chemotherapy for LS-SCLC with Bulky Tumor

“…Generally, sequential rather than concurrent chemoradiotherapy was the usual choose after 3-4 cycles of induction chemotherapy [18,19] because of the high incidence of toxicity. Additionally, intravenous etoposide and cisplatin was commonly used to combine with TRT.…”

Staging with PET-CT in Patients with Locally Advanced Non Small Cell Lung Cancer is Superior to Conventional Staging Methods in Terms of Survival

“…Therefore there is a disagreement among the oncologists in terms of whether surgery is necessary for treatment of locally advanced NSCLC or not. In order to improve the outcomes of the locally advanced NSCLC, sequential chemoradiation (Le Chevalier et al, 1992;Sause et al, 1995;Dillman et al, 1996;Brown et al., 2013), concurrent chemoradiation (Furuse et al, 1999;Zatloukal et al, 2004;Curran et al, 2011), concurrent chemoradiation with induction or consolidation (Albain et al, 2002;Gandara et al, 2003;Belani et al, 2005;Vokes et al, 2007;Driesen et al, 2013) have been investigated.…”

Positive therapy outcome of lung squamous cell cancer: A case report

“…The present patient survives healthily >10 years after diagnosis, which is much longer compared with the median overall survival of 21.8 months reported by Driesen et al (13) after induction with gemcitabine and cisplatin followed by concurrent chemoradiotherapy for patients with unresectable locally advanced NSCLC. The present study considered that the reasonable treatment plan, a free medical history and a positive psychological state contributed greatly to the patient's survival.…”