Of those receiving radiation alone, grade 3 or worse toxicity developed in 50%, vs 76% among those receiving the combined treatment. The most common nonhematologic side effects were stomatitis, nausea/vomiting, hearing loss, and weight loss.
• IMRT—In a prospective randomized trial,[27] 51 patients with early-stage nasopharyngeal cancer were treated by conventional radiation therapy or IMRT. The primary endpoint was the stimulated whole-salivary flow rate. The investigators hypothesized that the mean flow rate 12 months after conventional radiation therapy would be 0.05 mL/min, whereas after IMRT it would be at least 0.28 mL/min. A total of 46 patients were in remission 12 months after treatment. Their mean stimulated whole salivary flow rate was 0.05 mL/min among the controls vs 0.27 mL/min among those receiving IMRT (P < .05).
In another prospective randomized trial,[28] 60 patients with early-stage nasopharyngeal cancer were treated by conventional radiation therapy or IMRT. The primary endpoint was observer-rated xerostomia. The investigators hypothesized that 12 months after conventional radiation therapy, grade 2 or worse xerostomia would be observed in 80% of the control patients but in 40% or fewer of those receiving IMRT. Among the 58 patients still in remission 12 months after treatment, grade 2 or worse xerostomia was observed in 82.1% of the controls vs 39.3% of the IMRT recipients (P = .001). An observer-based result that close to the predicted levels may indicate observer bias, however.
These two studies suggest that when IMRT is employed for treating early-stage nasopharyngeal cancer instead of conventional radiation, the mean stimulated whole-salivary flow rate is increased while xerostomia (as assessed by the physician) is decreased.
No phase III trial has shown whether the survival of patients with nasopharyngeal cancer is better or worse if they are treated by advanced technologies instead of or in addition to traditional conformal radiation therapy, with or without cisplatin(Drug information on cisplatin).
Early Breast Cancer Treated by Lumpectomy
In one arm of a prospective randomized trial,[12] tamoxifen(Drug information on tamoxifen) plus traditional conformal radiation therapy (40 Gy in 16 fractions over 3½ weeks, followed by a 12.5-Gy boost in 5 fractions over 1 week) following lumpectomy was delivered to 386 women aged 50 years or older suffering from T1 or T2 node-negative breast cancer, between 1992 and 2000. Following the treatment, 7% of patients died within 5 years (2.5% due to breast cancer). The patterns of failure revealed that 0.6% suffered local failure within 5 years and 3.5% within 8 years, while 4.5% developed distant metastases.
The most common grade 3 side effects attributable to irradiation were fatigue in 1% and skin erythema in 1%.
• IMRT—In a prospective randomized trial,[29] 306 women with early breast cancer were randomized after lumpectomy to conventional radiation therapy (using standard wedge compensators) or IMRT between 1997 and 2000. The primary endpoint was change in breast appearance, scored from serial photographs taken before and after radiotherapy.
