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Poster Display session (Friday) (ID 65)
- Event: ELCC 2018
- Type: Poster Display session
- Presentations: 1
- Coordinates: 4/13/2018, 12:30 - 13:00, Hall 1
119P - Cisplatin/etoposide or paclitaxel/carboplatin with concurrent radiation therapy in stage IIIB non-small cell lung cancer: A one-year phase II trial at a low resource setting (ID 489)
12:30 - 13:00 | Presenting Author(s): M. Shuayb
Concurrent chemoradiation therapy (CCRT) has been established as the standard of care for patients with stage IIIB non-small cell lung cancer (NSCLC). The comparative benefits of two extensively used regimens: cisplatin/etoposide (PE) and paclitaxel/carboplatin (PC), with thoracic radiation therapy (TRT) remain largely undefined. To explore the distinct advantage of multiagent CCRT with taxane (PC) over CCRT with traditional platinum doublet therapy (PE), an interventional study was designed and conducted at the Department of Radiotherapy of Dhaka Medical College Hospital.
Patients were randomly assigned to receive the following treatments: PE arm, cisplatin (50 mg/m) on days 1,8 and 29 and etoposide (50 mg/m) on days 1–5 and 29–33 plus 45 Gy of TRT; PC arm, weekly paclitaxel (45 mg/m) and carboplatin (AUC = 2) plus 45 Gy of TRT. RECIST criteria, Kaplan-Meier method and RTOG morbidity criteria were employed to determine treatment response, survival and acute & late toxicity respectively. Student's t test, Chi squared test, Fisher's exact test and Log rank test were used to compare across the arms in different aspects.
A total of 60 patients (30 in each arm) were randomized. The objective response and disease control rate were 51.85% in PE and 60.71% in PC (P = 0.61) and 85.19% in PE and 78.57% in PC (P = 1) respectively. Treatment with PE had significant survival advantage in terms of 1-year overall survival (60.6% vs. 42.9%; P = 0.04) and 1 year progression free survival (44.6% vs. 31.0%; P = 0.04). Grade 3/4 neutropaenia occurred in 20% of PE and 16.67% of PC patients (P = 1). Acute oesophagitis (grade 1/2, 53.33% vs. 70%; grade 3/4, 13.33% vs. 30%, P < 0.01) and upper GI symptoms (grade 1/2: 63.33 vs. 100%; P < 0.01) were significantly more pronounced in PC group. PC arm developed significantly greater rate of pneumonitis (grade 1/2, 16.67% vs. 36.67%; grade 3/4, 0% vs. 10%; P = 0.02). PC arm had 4 treatment related deaths.
There was substantial incongruity between PE and PC based CCRT regimen in the treatment of stage IIIB NSCLC. With meticulous patient selection and follow up, CCRT with PE can be an acceptable protocol in this setting.
Clinical trial identification:
German Clinical Trials Register. DRKS00012599. Date 20.07.2017
Legal entity responsible for the study:
Ethical Review Committee of Dhaka Medical College Hospital, BD on 22.10.2014 (Ethical Clearance Certificate # ERC-DMC/ECC/2014/168). Registered by Bangladesh College of Physicians and Surgeons (BCPS) on 11.11.2014 (Registration # PSN-0037)
Has not received any funding
All authors have declared no conflicts of interest.
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