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Short fractionated radiotherapy versus multiple fractionated radiotherapy in patients with bone metastases: a meta-analysis of randomized clinical trial
S446
I. J. Radiation Oncology
2174
● Biology ● Physics
Volume 57, Number 2, Supplement, 2003
Critical Evaluation of the Temporal Change of Sexual Function after 3D Conformal Radiation Therapy for Prostate Cancer
R.K. Valicenti,1 A.G. Wernicke,1 K. DiEva,1 C. Houser,1 E. Pequignot2 Radiation Oncology, Thomas Jefferson University, Philadelphia, PA, 2Medicine, Thomas Jefferson University, Philadelphia, PA
1
Purpose/Objective: To improve our ability to predict, and thus to identify a means to better preserve, sexual function (SF) after radiation therapy for prostate cancer, we analyzed the development of SF over time. To accomplish this, we made use of serially collected data of erectile dysfunction (ED), ejaculatory difficulty (EJD), and overall satisfaction with sex life (QOL) and compared them to the pretreatment baseline information. Materials/Methods: We evaluated 78 consecutive men with clinically localized prostate cancer, who received 3 dimensional conformal radiation therapy (3D CRT) alone (median radiation dose of 73.8 Gy, range 66.6 to 79.2 Gy) from January 1996 to April 2001, and were sexually potent (ED⫽ 0%) at baseline. Their SF was evaluated serially with validated, self-administered questionnaires at baseline, 1 year, 2, 3, and 4 years after completion of treatment. ED was defined as the inability to have an erection firm enough for sexual intercourse, and EJD as inability to ejaculate. We analyzed factors including diabetes, cardiovascular disease, or tobacco use and treatment parameters such as total radiation dose, and treatment volume. Once patients were started on sildenafil citrate, subsequent follow-up information was excluded from the analysis. Results: The median follow-up time was 23 months, with a range from 3 months to 61 months. None of patient or treatment related factors were significant predictors of 3D CRT induced ED. The table summarizes parameters of SF with respect to time. The reduction in ED scores as compared to pretreatment baseline values was significant (p⬍0.001, Signed Rank Test). Conclusions: Our data suggest that the greatest relative reduction in SF, relative to pretreatment baseline, occurs between 1 and 2 years after 3D CRT. Thus, this time interval is important in assessing dosimetric parameters as predictors of SF. The 2 year endpoint is a reliable measure for the development of ED and applies to clinical assessment as well as to counseling of men after radiation therapy for prostate cancer.
2175
Short Fractionated Radiotherapy versus Multiple Fractionated Radiotherapy in Patients with Bone Metastases: A Meta-Analysis of Randomized Clinical Trial
F. Fiorica,1,2 G. De Marco,2 C. Camma’,3 A. Venturi,3 M. Candela,4 G. Fiorica,4 A. Falchi,2 F. Cartei1 Radioterapia Oncologica, Azienda Ospedaliera Universitaria S.Anna, Ferrara, Italy, 2Cattedra Di Radioterapia , Policlinico Di Modena, Modena, Italy, 3IBIM, Consiglio Nazionale Delle Ricerche, Palermo, Italy, 4Universita’ Di Palermo, Palermo, Italy 1
Purpose/Objective: Background: The benefit of short fractonated radiotherapy schedules (SFRS) treatments for bone metastastes from various primitive histology has been extensively studied, but data on the best schedule are still controversial. The purpose of the study was to assess the effectiveness of SFRS versus multiple fractionated radiotherapy schedules (MFRS) for bone metastases from various primitive histology in the reduction of pain relief.
Proceedings of the 45th Annual ASTRO Meeting
Materials/Methods: Methods: Strategies to identify published research included computerized (MEDLINE 1970-2002) and manual searches. Nine randomized controlled trials (RCTs) comparing various schedules to SFRS were identified. These RCTs included 3078 patients, 1532 of whom received MFRS. Data on population, intervention and outcomes were extracted from each RCT according to the treatment-related method and combined by DerSimonian and Laird method. Results: Results: No difference was observed comparing SFRS and MFRS treatment, the same results in overall response at 1 and 3 months (odds ratio (OR 0.86; confidence interval [CI] 0.68-1.09; p⫽0.2, at 1 month and OR 1.03; [CI] 0.88-1.21;p⫽0.7 at 3 months) and in complete response at 1 and 3 months (OR 1.13; [CI] 0.96-1.34;p⫽0.14 at 1 month and OR 0.96; [CI] 0.79-1.16;p⫽0.7 at 3 months) was obtained. No difference in analgesic not required rate was also observed. Conclusions: Conclusions: In patients with bone metastases ( various histology) short fractionation schedules shows the same efficacy compared to MFRS in pain reduction at 1 and 3 months. Moreover, the SFRS tretment is related to a lower cost and leads to possibility of re-treatment.
2176
Plaque Radiotherapy for Large Posterior Uveal Melanomas (> 8 mm thick) in 354 Consecutive Patients 1
J.E. Freire, C.L. Shields,2 J.A. Shields,2 H. Demirci,2 A. Youseff,3 A. Young,1 J. Carter,2 M. Naseripour2 Radiation Oncology, MCP-Hahnemann University, Philadelphia, PA, 2Ocular Oncology Service, Wills Eye Hospital, Philadelphia, PA, 3Radiation Oncology, West Jersey Hospital at Voorhees, Voorhees, NJ 1
Purpose/Objective: To assess treatment complications and tumor control after plaque radiotherapy for large posterior uveal melanoma measuring 8 mm or greater in thickness Materials/Methods: This is a prospective non-comparative interventional case series. Three hundred fifty-four patients each of whom had a posterior uveal melanoma measuring 8 mm or greater in thickness, treated with plaque radiotherapy using I-125, Ru-106, Co-60 and Ir-192 were analyzed. The four endpoints for evaluation included poor final visual acuity (20/200 or worse), enucleation, local tumor recurrence and metastasis. The clinical data regarding patient features, tumor features and radiation parameters were analyzed for their impact on these four main outcomes, using Cox proportional hazards regression models. Results: Using Kaplan-Meier estimates, final visual acuity was poor in 57% at 5 years and 89% at 10 years follow-up. Using multivariate analysis, the most important risk factors for poor visual acuity included: retinal invasion by melanoma, increasing patient age, Iodine 125 (I125) isotope, and ⬍2 mm distance to the optic disc.Treatment related complications at 5 years included proliferative retinopathy (25%), maculopathy (24%), papillopathy (22%), cataract (66%) neovascular glaucoma (21%), vitreous hemorrhage (23%) and scleral necrosis (7%). Enucleation was necessary in 24% at 5 years and 34% at 10 years follow-up. Using multivariate analysis, the risk factors for enucleation included: left eye, peripheral tumor margin anterior rather than posterior to the equator, increasing tumor thickness, and isotope Ruthenium-106 (Ru-106).Using Kaplan-Meier estimates, local tumor recurrence was found in 9% at 5 years and 13% at 10 years follow-up. Using multivariate analysis, risk factors for tumor recurrence included Ru106 radioisotope and ciliary body involvement with tumor.Tumor-related metastases were found in 30% at 5 years and 55% at 10 years follow-up. Using multivariate analysis, risk factors for metastases included infero-temporal meridian, anterior extension of the tumor to the iris root, increasing tumor base, and posterior margin ⬍ 2 mm from the optic nerve. Conclusions: Plaque brachytherapy provided tumor control at 10 years in 87% of patients with selected large posterior uveal melanomas (ⱖ8 mm thick) that otherwise would have been managed with enucleation.The large intraocular mass and associated features and radiation complications led to poor visual acuity in most patients. At 10 years follow-up, enucleation was necessary in 34% of patients and metastasis developed in 55% of patients.
2177
Does Immune Compromised State Influence Tumor Control in Patients with Epithelial Skin Cancer of the Head and Neck Region?
J.A. Asper, K. Chao, G. Ozyigit, A.S. Garden, W.H. Morrison, D.I. Rosenthal, K.K. Ang Department of Radiation Oncology, The University of Texas, M. D. Anderson Cancer Center, Houston, TX Purpose/Objective: To evaluate the impact of immune compromised state on the therapeutic outcome of patients with epithelial skin cancer in head and neck region. Materials/Methods: Between January 1978 and December 1999, there were 288 patients (118 initial tumors and 170 recurrent tumors) with epithelial skin cancer of head and neck region treated with radiotherapy. There were 21 immune compromised (IC) patients: either taking immune-suppressive drugs after organ transplantation (4 patients), crohn’s disease (2 patients), rheumatoid arthritis (1 patient), and systemic lupus (1 patient), and receiving chemotherapy for lymphoma (6 patients) and leukemia (6 patients). There was one patient with HIV infection. Electron beam was used in 163, superficial X-ray in 23, photons in 27, combined electron and photon in 75 patients. The mean daily fraction dose and mean total radiation dose to the primary tumor was 2.3⫾0.8 Gy and 57.6⫾7.04 Gy for non-immune compromised patients (NIC); 2.5⫾1.45 Gy and 55.14⫾11.7 Gy for IC, respectively. All living patients were followed for a minimum of 2 years. Median follow up was 53 months for NIC, and 41 months for IC patients. Immune state, nodal stage, total radiation dose, fraction dose, multifocality, recurrent vs. primary tumor, pathology, nodal stage, size of primary tumor, surgical margin, perineural invasion, muscle invasion, cartilage, and bone invasion were analyzed as prognostic factors in univariate and multivariate analysis. The difference in tumor and treatment characteristics between IC and NIC patients were tested by ⌾2 and Mann-Whitney-U tests. Local control (LC), nodal control (NC), and distant metastasis-free control (DMC) rates were calculated by Kaplan-Meier curves. Log rank test was used for univariate analyses. Multivariate analyses were performed by Cox proportional hazards regression model. All significance tests were 2-sided.
S447
I. J. Radiation Oncology
2174
● Biology ● Physics
Volume 57, Number 2, Supplement, 2003
Critical Evaluation of the Temporal Change of Sexual Function after 3D Conformal Radiation Therapy for Prostate Cancer
R.K. Valicenti,1 A.G. Wernicke,1 K. DiEva,1 C. Houser,1 E. Pequignot2 Radiation Oncology, Thomas Jefferson University, Philadelphia, PA, 2Medicine, Thomas Jefferson University, Philadelphia, PA
1
Purpose/Objective: To improve our ability to predict, and thus to identify a means to better preserve, sexual function (SF) after radiation therapy for prostate cancer, we analyzed the development of SF over time. To accomplish this, we made use of serially collected data of erectile dysfunction (ED), ejaculatory difficulty (EJD), and overall satisfaction with sex life (QOL) and compared them to the pretreatment baseline information. Materials/Methods: We evaluated 78 consecutive men with clinically localized prostate cancer, who received 3 dimensional conformal radiation therapy (3D CRT) alone (median radiation dose of 73.8 Gy, range 66.6 to 79.2 Gy) from January 1996 to April 2001, and were sexually potent (ED⫽ 0%) at baseline. Their SF was evaluated serially with validated, self-administered questionnaires at baseline, 1 year, 2, 3, and 4 years after completion of treatment. ED was defined as the inability to have an erection firm enough for sexual intercourse, and EJD as inability to ejaculate. We analyzed factors including diabetes, cardiovascular disease, or tobacco use and treatment parameters such as total radiation dose, and treatment volume. Once patients were started on sildenafil citrate, subsequent follow-up information was excluded from the analysis. Results: The median follow-up time was 23 months, with a range from 3 months to 61 months. None of patient or treatment related factors were significant predictors of 3D CRT induced ED. The table summarizes parameters of SF with respect to time. The reduction in ED scores as compared to pretreatment baseline values was significant (p⬍0.001, Signed Rank Test). Conclusions: Our data suggest that the greatest relative reduction in SF, relative to pretreatment baseline, occurs between 1 and 2 years after 3D CRT. Thus, this time interval is important in assessing dosimetric parameters as predictors of SF. The 2 year endpoint is a reliable measure for the development of ED and applies to clinical assessment as well as to counseling of men after radiation therapy for prostate cancer.
2175
Short Fractionated Radiotherapy versus Multiple Fractionated Radiotherapy in Patients with Bone Metastases: A Meta-Analysis of Randomized Clinical Trial
F. Fiorica,1,2 G. De Marco,2 C. Camma’,3 A. Venturi,3 M. Candela,4 G. Fiorica,4 A. Falchi,2 F. Cartei1 Radioterapia Oncologica, Azienda Ospedaliera Universitaria S.Anna, Ferrara, Italy, 2Cattedra Di Radioterapia , Policlinico Di Modena, Modena, Italy, 3IBIM, Consiglio Nazionale Delle Ricerche, Palermo, Italy, 4Universita’ Di Palermo, Palermo, Italy 1
Purpose/Objective: Background: The benefit of short fractonated radiotherapy schedules (SFRS) treatments for bone metastastes from various primitive histology has been extensively studied, but data on the best schedule are still controversial. The purpose of the study was to assess the effectiveness of SFRS versus multiple fractionated radiotherapy schedules (MFRS) for bone metastases from various primitive histology in the reduction of pain relief.
Proceedings of the 45th Annual ASTRO Meeting
Materials/Methods: Methods: Strategies to identify published research included computerized (MEDLINE 1970-2002) and manual searches. Nine randomized controlled trials (RCTs) comparing various schedules to SFRS were identified. These RCTs included 3078 patients, 1532 of whom received MFRS. Data on population, intervention and outcomes were extracted from each RCT according to the treatment-related method and combined by DerSimonian and Laird method. Results: Results: No difference was observed comparing SFRS and MFRS treatment, the same results in overall response at 1 and 3 months (odds ratio (OR 0.86; confidence interval [CI] 0.68-1.09; p⫽0.2, at 1 month and OR 1.03; [CI] 0.88-1.21;p⫽0.7 at 3 months) and in complete response at 1 and 3 months (OR 1.13; [CI] 0.96-1.34;p⫽0.14 at 1 month and OR 0.96; [CI] 0.79-1.16;p⫽0.7 at 3 months) was obtained. No difference in analgesic not required rate was also observed. Conclusions: Conclusions: In patients with bone metastases ( various histology) short fractionation schedules shows the same efficacy compared to MFRS in pain reduction at 1 and 3 months. Moreover, the SFRS tretment is related to a lower cost and leads to possibility of re-treatment.
2176
Plaque Radiotherapy for Large Posterior Uveal Melanomas (> 8 mm thick) in 354 Consecutive Patients 1
J.E. Freire, C.L. Shields,2 J.A. Shields,2 H. Demirci,2 A. Youseff,3 A. Young,1 J. Carter,2 M. Naseripour2 Radiation Oncology, MCP-Hahnemann University, Philadelphia, PA, 2Ocular Oncology Service, Wills Eye Hospital, Philadelphia, PA, 3Radiation Oncology, West Jersey Hospital at Voorhees, Voorhees, NJ 1
Purpose/Objective: To assess treatment complications and tumor control after plaque radiotherapy for large posterior uveal melanoma measuring 8 mm or greater in thickness Materials/Methods: This is a prospective non-comparative interventional case series. Three hundred fifty-four patients each of whom had a posterior uveal melanoma measuring 8 mm or greater in thickness, treated with plaque radiotherapy using I-125, Ru-106, Co-60 and Ir-192 were analyzed. The four endpoints for evaluation included poor final visual acuity (20/200 or worse), enucleation, local tumor recurrence and metastasis. The clinical data regarding patient features, tumor features and radiation parameters were analyzed for their impact on these four main outcomes, using Cox proportional hazards regression models. Results: Using Kaplan-Meier estimates, final visual acuity was poor in 57% at 5 years and 89% at 10 years follow-up. Using multivariate analysis, the most important risk factors for poor visual acuity included: retinal invasion by melanoma, increasing patient age, Iodine 125 (I125) isotope, and ⬍2 mm distance to the optic disc.Treatment related complications at 5 years included proliferative retinopathy (25%), maculopathy (24%), papillopathy (22%), cataract (66%) neovascular glaucoma (21%), vitreous hemorrhage (23%) and scleral necrosis (7%). Enucleation was necessary in 24% at 5 years and 34% at 10 years follow-up. Using multivariate analysis, the risk factors for enucleation included: left eye, peripheral tumor margin anterior rather than posterior to the equator, increasing tumor thickness, and isotope Ruthenium-106 (Ru-106).Using Kaplan-Meier estimates, local tumor recurrence was found in 9% at 5 years and 13% at 10 years follow-up. Using multivariate analysis, risk factors for tumor recurrence included Ru106 radioisotope and ciliary body involvement with tumor.Tumor-related metastases were found in 30% at 5 years and 55% at 10 years follow-up. Using multivariate analysis, risk factors for metastases included infero-temporal meridian, anterior extension of the tumor to the iris root, increasing tumor base, and posterior margin ⬍ 2 mm from the optic nerve. Conclusions: Plaque brachytherapy provided tumor control at 10 years in 87% of patients with selected large posterior uveal melanomas (ⱖ8 mm thick) that otherwise would have been managed with enucleation.The large intraocular mass and associated features and radiation complications led to poor visual acuity in most patients. At 10 years follow-up, enucleation was necessary in 34% of patients and metastasis developed in 55% of patients.
2177
Does Immune Compromised State Influence Tumor Control in Patients with Epithelial Skin Cancer of the Head and Neck Region?
J.A. Asper, K. Chao, G. Ozyigit, A.S. Garden, W.H. Morrison, D.I. Rosenthal, K.K. Ang Department of Radiation Oncology, The University of Texas, M. D. Anderson Cancer Center, Houston, TX Purpose/Objective: To evaluate the impact of immune compromised state on the therapeutic outcome of patients with epithelial skin cancer in head and neck region. Materials/Methods: Between January 1978 and December 1999, there were 288 patients (118 initial tumors and 170 recurrent tumors) with epithelial skin cancer of head and neck region treated with radiotherapy. There were 21 immune compromised (IC) patients: either taking immune-suppressive drugs after organ transplantation (4 patients), crohn’s disease (2 patients), rheumatoid arthritis (1 patient), and systemic lupus (1 patient), and receiving chemotherapy for lymphoma (6 patients) and leukemia (6 patients). There was one patient with HIV infection. Electron beam was used in 163, superficial X-ray in 23, photons in 27, combined electron and photon in 75 patients. The mean daily fraction dose and mean total radiation dose to the primary tumor was 2.3⫾0.8 Gy and 57.6⫾7.04 Gy for non-immune compromised patients (NIC); 2.5⫾1.45 Gy and 55.14⫾11.7 Gy for IC, respectively. All living patients were followed for a minimum of 2 years. Median follow up was 53 months for NIC, and 41 months for IC patients. Immune state, nodal stage, total radiation dose, fraction dose, multifocality, recurrent vs. primary tumor, pathology, nodal stage, size of primary tumor, surgical margin, perineural invasion, muscle invasion, cartilage, and bone invasion were analyzed as prognostic factors in univariate and multivariate analysis. The difference in tumor and treatment characteristics between IC and NIC patients were tested by ⌾2 and Mann-Whitney-U tests. Local control (LC), nodal control (NC), and distant metastasis-free control (DMC) rates were calculated by Kaplan-Meier curves. Log rank test was used for univariate analyses. Multivariate analyses were performed by Cox proportional hazards regression model. All significance tests were 2-sided.
S447