STOCKHOLM – Patients aged 71 years and older with advanced non–small cell lung cancer showed significantly greater survival with carboplatin chemotherapy plus concurrent radiation than with radiotherapy alone in a Japan Clinical Oncology Group trial that included only elderly patients.
Median overall survival was significantly longer, at 22.4 months, for those who received chemoradiotherapy, compared with 16.9 months for those having radiation therapy alone (hazard ratio, 0.68; P = .0179). Median progression-free survival was also significantly longer (8.9 months) for those receiving chemoradiotherapy, compared with 6.8 months for those with radiation therapy alone (HR, 0.66; P = .0044).
"This is the first trial demonstrating the clinically significant benefits of concurrent chemoradiation therapy in elderly patients with stage III non–small-cell lung cancer," Dr. Shinji Atagi said at the European Multidisciplinary Cancer Congress.
"This combined modality is considered as the standard treatment for this population [in Japan]," added Dr. Atagi of the National Hospital Organization Kinki-Chuo Chest Medical Center in Osaka, Japan.
Invited discussant Dr. Johanna Kazmierska shared the enthusiasm about the trial and its results. "The study suggests that age is not the only determinant of management of the [older] patient. The overall patient status [usually] is not taken into consideration," said Dr. Kazmierska of the radiotherapy department at the Greater Poland Cancer Centre in Poznan, Poland.
"Assessment of potential differences in treatment results – for example, overall survival – [provides] a strong argument for us in the discussion of the treatment of elderly patients," she added.
Patients were included in the trial if they had cytologically and/or histologically confirmed stage IIA (except T3N1M0) or IIIB non–small cell lung cancer (NSCLC). They had to be at least 71 years of age and have had no previous chemotherapy or radiotherapy. They also could not be candidates for cisplatin-based combination chemotherapy.
Patients were randomly assigned to the radiotherapy (RT) arm or the chemoradiotherapy (CRT) arm. In all, 98 patients were randomized to receive RT alone and 99 patients received CRT. The median age for both groups was 77 years.
The RT consisted of 60 Gy in 30 fractions over 6 weeks. In the CRT arm, patients received the same radiotherapy dose as in the RT arm as well as concurrent intravenous administration of carboplatin (30 mg/m2 in a 30-minute infusion) 1 hour before every radiation treatment up to the first 20 fractions.
In March 2011 – after the second interim analysis was performed – the Data and SafetyMonitoring Board recommended early publication of this trial in accordance with a prespecified rule.
The overall objective response rate (complete plus partial response) was 52% in the CRT arm vs. 45% in the RT arm. The difference between the two groups was not significant, however.
Safety results showed 64% and 59% of patients in the CRT arm had grade 3/4 leukocytopenia and neutropenia, but there were no grade 3/4 cases of either side effect in the RT arm. The CRT group also had a greater incidence of grade 3/4 infection (15% vs. 4%). Four treatment-related deaths occurred in the RT arm, and three occurred in the CRT arm.
The joint congress was sponsored by the European Cancer Organization (ECCO), the European Society for Medical Oncology (ESMO), and the European Society for Radiation and Oncology (ESTRO).
The study was sponsored by the Japan Clinical Oncology Group, with support from Japanese Ministry of Health, Labour, and Welfare. No personal disclosures were presented.