Short- or Long-Course Radiotherapy for Bone Metastases?
Short- or Long-Course Radiotherapy for Bone Metastases?
Painful bone metastases can be effectively palliated with radiation therapy, but debate exists among radiation oncologists as to the optimal treatment schedule. A typical prescription involves 30 Gy delivered in 10 fractions, but a number of studies have demonstrated equivalent pain relief with shorter, lower-dose treatments. Is a single-fraction course of radiotherapy as effective as a longer course involving multiple fractions?
To compare the palliative effects of a single 8 Gy fraction of radiotherapy with a 30 Gy course delivered in 10 treatment fractions, in patients with painful bone metastasis.
This prospective, randomized, phase III study recruited men and women with primary prostate or breast cancers between 1998 and 2001. Inclusion criteria were radiographic evidence of bone metastasis, pain in the area of bone metastasis, a Karnofsky performance status of ≥40, and a life expectancy of ≥3 months. Exclusion criteria included prior radiation therapy, palliative surgery, or the presence of pathologic fracture at the site of painful metastasis. Patients were randomized to receive 8 Gy of radiation delivered in one fraction, or 30 Gy of radiation delivered in 10 3 Gy fractions over a 2-week period. Treatment responses were evaluated using follow-up questionnaires and telephone interviews.
The primary endpoints were pain relief (assessed by Brief Pain Inventory worst pain score), and narcotic relief.
Of 898 eligible patients, 455 were randomized to the 8 Gy arm, and 443 were randomized to the 30 Gy arm. Patient characteristics were similar between the two groups. Overall, the treatment was well tolerated. Grade 2-4 acute toxicity occurred more frequently in the 30-Gy group compared with the 8-Gy group (17% versus 10%, P = 0.002). The incidence of late toxicity ≥grade 2 was 4% in both groups. A 3-month Brief Pain Inventory assessment was available for 288 patients in the 8 Gy arm and 285 patients in the 30 Gy arm. The overall response rate was 66%. Complete and partial response rates were 15% and 50%, respectively, in the 8 Gy arm, compared with 18% and 48%, respectively, in the 30 Gy arm (P = 0.6). At 3 months, 33% of patients in the 8 Gy arm and 32% of patients in the 30 Gy arm no longer used narcotic medications. Pathologic fractures occurred within the treatment field of 5% and 4% of patients in the 8 Gy and 30 Gy arms, respectively. Significantly more patients in the 8 Gy arm were re-treated compared with the 30 Gy arm (3-year re-treatment rates: 18% versus 9%; P <0.001). Even when stratified by the number of painful treatment sites, treatment site weight-bearing status, pretreatment pain score, or bisphosphonate use, differences in response between the two treatment groups were not significant.
At 3 months, a single dose of 8 Gy is equivalent to 30 Gy in providing pain relief and narcotic relief to patients with painful bone metastasis. There was a higher re-treatment rate, but less acute toxicity, among patients in the 8 Gy arm compared with the 30 Gy arm.
Painful bone metastases can be effectively palliated with radiation therapy, but debate exists among radiation oncologists as to the optimal treatment schedule. A typical prescription involves 30 Gy delivered in 10 fractions, but a number of studies have demonstrated equivalent pain relief with shorter, lower-dose treatments. Is a single-fraction course of radiotherapy as effective as a longer course involving multiple fractions?
To compare the palliative effects of a single 8 Gy fraction of radiotherapy with a 30 Gy course delivered in 10 treatment fractions, in patients with painful bone metastasis.
This prospective, randomized, phase III study recruited men and women with primary prostate or breast cancers between 1998 and 2001. Inclusion criteria were radiographic evidence of bone metastasis, pain in the area of bone metastasis, a Karnofsky performance status of ≥40, and a life expectancy of ≥3 months. Exclusion criteria included prior radiation therapy, palliative surgery, or the presence of pathologic fracture at the site of painful metastasis. Patients were randomized to receive 8 Gy of radiation delivered in one fraction, or 30 Gy of radiation delivered in 10 3 Gy fractions over a 2-week period. Treatment responses were evaluated using follow-up questionnaires and telephone interviews.
The primary endpoints were pain relief (assessed by Brief Pain Inventory worst pain score), and narcotic relief.
Of 898 eligible patients, 455 were randomized to the 8 Gy arm, and 443 were randomized to the 30 Gy arm. Patient characteristics were similar between the two groups. Overall, the treatment was well tolerated. Grade 2-4 acute toxicity occurred more frequently in the 30-Gy group compared with the 8-Gy group (17% versus 10%, P = 0.002). The incidence of late toxicity ≥grade 2 was 4% in both groups. A 3-month Brief Pain Inventory assessment was available for 288 patients in the 8 Gy arm and 285 patients in the 30 Gy arm. The overall response rate was 66%. Complete and partial response rates were 15% and 50%, respectively, in the 8 Gy arm, compared with 18% and 48%, respectively, in the 30 Gy arm (P = 0.6). At 3 months, 33% of patients in the 8 Gy arm and 32% of patients in the 30 Gy arm no longer used narcotic medications. Pathologic fractures occurred within the treatment field of 5% and 4% of patients in the 8 Gy and 30 Gy arms, respectively. Significantly more patients in the 8 Gy arm were re-treated compared with the 30 Gy arm (3-year re-treatment rates: 18% versus 9%; P <0.001). Even when stratified by the number of painful treatment sites, treatment site weight-bearing status, pretreatment pain score, or bisphosphonate use, differences in response between the two treatment groups were not significant.
At 3 months, a single dose of 8 Gy is equivalent to 30 Gy in providing pain relief and narcotic relief to patients with painful bone metastasis. There was a higher re-treatment rate, but less acute toxicity, among patients in the 8 Gy arm compared with the 30 Gy arm.
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