Lung Cancer.pdf

Nonsurgical Treatment of Non–Small Cell Lung Cancer 151
plete response rates were 37% in arm 1 and 42% in arm 2. There was a significant
difference in time to in-field progression favoring arm 2 (45% in arm
1 vs 26% in arm 2 at 2 years and 49% in arm 1 vs 30% in arm 2 at 4 years) (P
.009). The median overall survival times were 16.4 months in arm 1 and
15.5 months in arm 2 (P .88). There was no significant survival difference
between the 2 arms at 2 years or 4 years.
RTOG trial 94–10, the results of which were published in 2000, was designed
to compare concomitant versus sequential chemotherapy and thoracic
radiation therapy in patients with inoperable stage II or III NSCLC
with a Karnofsky performance status score higher than 70 and weight loss
less than 5% (Komaki et al, 2000b). In this trial, patients were randomly assigned
to receive sequential chemotherapy and radiation therapy (vinblastine
and cisplatin for 2 cycles followed by 63 Gy in 7 weeks) (arm 1);
chemotherapy (vinblastine and cisplatin) with concurrent once-daily radiation
therapy (63 Gy in 7 weeks) (arm 2); or chemotherapy (oral etoposide
and cisplatin) with concurrent twice-daily radiation therapy (69.6 Gy in 1.2-
Gy twice-daily fractions in 6 weeks) (arm 3). Treatment details are given in
Table 8–7. Radiation therapy was given using conventional techniques
rather than 3-dimensional conformal radiation therapy techniques.
Table 8–7. Schema for Radiation Therapy Oncology Group Trial 94–10,
a 3-Arm Phase III Study of Concomitant versus Sequential
Chemotherapy and Thoracic Radiation Therapy for Patients
with Locally Advanced, Inoperable NSCLC
Stratification criteria
Stage: II vs IIIA vs IIIB
Karnofsky performance status 90–100 vs 70–80
Arm 1 (chemotherapy followed by once-daily radiation therapy)
Vinblastine: 5 mg/m2 intravenous bolus weekly for first 5 weeks
Cisplatin: 100 mg/m2 given intravenously over 30–60 minutes, days 1 and 29
Radiation therapy: 63 Gy in 34 daily fractions over 7 weeks (1.8 Gy x 25
fractions, then 2.0 Gy x 9 fractions) beginning day 50
Arm 2 (concurrent chemotherapy and once-daily radiation therapy)
Vinblastine: 5 mg/m2 intravenous bolus weekly for first 5 weeks
Cisplatin: 100 mg/m2 given intravenously over 30–60 minutes, days 1 and 29
Radiation therapy: 63 Gy in 34 daily fractions over 7 weeks (1.8 Gy x 25
fractions, then 2.0 Gy x 9 fractions) beginning day 1
Arm 3 (concurrent chemotherapy and twice-daily radiation therapy)
Etoposide: 50 mg by mouth twice daily x 10 only on radiation therapy days
1–5 and 8–12 (75 mg/day if body surface area 1.7 m2 )
Cisplatin: 50 mg/m2 intravenously over 30–60 minutes on days 1, 8, 29, and 36
Radiation therapy: 69.6 Gy in 58 twice-daily 1.2-Gy fractions (at least 6 hours
apart) over 6 weeks beginning day 1