A phase II trial, feasibility of combination of daily cisplatinum and accelerated radiotherapy via concomitant boost in stage III non-small cell lung cancer.
OBJECTIVE
A prospective phase II trial was conducted by the Institute of Oncology, Istanbul University in December 1994 on patients with locally-advanced non-small cell lung cancer to assess acute toxicity and the feasibility of a combination of radiosensitizer and accelerated radiotherapy with concomitant boost.


METHODS
Patients were irradiated using 'large' fields (primary tumour and locoregional lymph nodes) with 1.8 Gy per fraction, five fractions a week. Reduced 'boost' fields (primary and involved nodes only) were also irradiated twice-weekly 1.8 Gy per fraction in ten fractions concomitantly 6 h after the administration of large field. Total radiation dose was 63 Gy in 5 weeks (45 Gy 'large' fields and 18 Gy 'boost'). The maximum allowed dose to the spinal cord was 3750 cGy. Cisplatinum, 6 mg/m2 was given daily just before 'large' field irradiation.


RESULTS
As of January 1997, 15 patients were evaluated (median follow-up of 12.5 months with a range of 5.5-23 months). The overall acute toxicity rate was 38% and Grade 3 acute toxicity was 8%. Grade 4 or greater acute toxicities were not observed. The overall rate of cisplatinum-induced nausea and vomiting was 80% (severe in 60%), but all were easily treated with antiemetics. Complete response rate (clinical and radiological) was 40% and an overall response rate was 73%. Median survival was 16 months and progression-free survival was 5.5 months (range of 2.5-21 months).


CONCLUSIONS
Toxicity was well tolerated and no treatment-related death occurred with this combined treatment regimen. Although it appears that better local control rates can be achieved, additional phase II/III studies are needed.
Sarihan
S
S
Department of Radiation Oncology, Uludağ University Medical College, Bursa, Turkey.
Darendeliler
E
E
Kizir
A
A
Tuncel
N
N
Oral
E N
EN
Karadeniz
A
A
Bilge
N
N
D000328:Adult; D000368:Aged; D000970:Antineoplastic Agents / Q000009:adverse effects / Q000627:therapeutic use*; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy / Q000532:radiotherapy*; D002945:Cisplatin / Q000009:adverse effects / Q000627:therapeutic use*; D003131:Combined Modality Therapy / Q000009:adverse effects; D016001:Confidence Intervals; D019583:Dose Fractionation, Radiation; D005260:Female; D006801:Humans; D008175:Lung Neoplasms / Q000188:drug therapy / Q000532:radiotherapy*; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D011838:Radiation-Sensitizing Agents / Q000009:adverse effects / Q000627:therapeutic use*; D011878:Radiotherapy / Q000009:adverse effects / Q000379:methods; D016019:Survival Analysis
D000970:Antineoplastic Agents; D011838:Radiation-Sensitizing Agents; D002945:Cisplatin