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Long-term Quality of Life after Chemoradiation for Anal Cancer
I. J. Radiation Oncology d Biology d Physics
S104
Volume 72, Number 1, Supplement, 2008
immediately after treatment. Two of the 5 subscales, pain/discomfort and usual activity, had a significant trend in increasing reported level 3 but the absolute number of patients reporting this level of problems was approximately #5%. Conclusions: This study of EQ-5D is unique in demonstrating very high levels of overall quality of life in patients treated with breast-conserving surgery and radiation even up to 15 years after treatment. These mean health states are comparable to those reported for the general adult U.S. population. Author Disclosure: G.M. Freedman, None; P.R. Anderson, None; T. Li, None; N. Nicolaou, None; A. Konski, None.
230
Long-term Quality of Life after Chemoradiation for Anal Cancer
P. Das, S. B. Cantor, C. L. Parker, J. B. Zampieri, A. Baschnagel, C. Eng, M. E. Delclos, S. Krishnan, N. A. Janjan, C. H. Crane U.T. M.D. Anderson Cancer Center, Houston, TX Purpose/Objective(s): Our objective was to evaluate long-term quality of life in patients treated with definitive chemoradiation for anal cancer. Materials/Methods: The study population included patients treated with definitive chemoradiation for squamous cell anal carcinoma between January 1993 and December 2003, with a minimum of 2-year follow-up after completion of chemoradiation, who were alive at the time of the study, had verifiable mailing addresses, and could speak English. Eligible subjects (n = 80) were mailed a questionnaire that included the Functional Assessment of Cancer Therapy-Colorectal (FACT-C), a 34-item instrument having a maximum score of 136, with higher scores indicating better quality of life. The questionnaire also included the Medical Outcomes Study (MOS) Sexual Problems Scale, a 4-item instrument having a maximum score of 100, with higher scores indicating worse sexual function. Furthermore, the questionnaire had 13 questions on demographic characteristics and co-morbidities. Results: Of the eligible subjects, 32 (40%) provided informed consent and completed the questionnaire. There were no significant differences in clinical and demographic characteristics between the respondents and non-respondents. Among the 32 respondents, the median dose of radiotherapy was 55 Gy (range 39.6-59.4 Gy), 72% had received concurrent 5-fluorouracil and cisplatin, 19% had received concurrent capecitabine and cisplatin, and 6% had received concurrent 5-fluorouracil and mitomycin C. The median interval between chemoradiation and survey participation was 5 years (range 3-13 years). The median total FACT-C score was 108 (range 47-128), out of a maximum (best possible) score of 136. Patients who reported depression or anxiety had significantly lower total FACT-C scores than those who did not report depression or anxiety (median score 92 vs. 109, p = 0.006). Patients with age \51 years at the time of treatment had significantly lower total FACT-C scores than those with age $51 years (median score 106 vs. 114, p = 0.033). The median score on the physical, social/family, emotional, functional, and colorectal subscales of FACT-C was 20, 23, 21, 22, and 21, out of maximum (best possible) score of 28, 28, 24, 28, and 28, respectively. The median score on the MOS sexual functioning scale was 67 (range 0-100), out of a maximum (worst possible) score of 100. Conclusions: Patients treated with chemoradiation for anal cancer reported acceptable overall quality of life scores, but poor sexual functioning scores. Investigations are warranted into treatment techniques that could reduce sexual morbidity, such as intensity modulated radiation therapy (IMRT) to spare genitalia. Author Disclosure: P. Das, None; S.B. Cantor, None; C.L. Parker, None; J.B. Zampieri, None; A. Baschnagel, None; C. Eng, None; M.E. Delclos, None; S. Krishnan, None; N.A. Janjan, None; C.H. Crane, None.
231
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232
Long-term Results of a Dose Searching Trial in Chordomas and Chondrosarcomas of the Skull Base and Cervical Spine
J. E. Munzenrider1,2, B. Y. Yeap1, T. F. DeLaney1, L. Marucci3, M. M. Fitzek4, S. E. Dean1, N. J. Liebsch1 1 Massachusetts General Hospital, Boston, MA, 2Harvard Medical School, Boston, MA, 3Regina Elena National Cancer Institute, Rome, Italy, 4Midwest Proton Therapy Center, Bloomington, IN
Purpose/Objective(s): To report a prospective randomized Phase I/II dose searching trial in adult patients with chordomas and chondrosarcomas of the skull base and cervical spine treated with high dose, 3D-conformal fractionated proton-photon therapy. Materials/Methods: A prospective randomized Phase I/II dose searching trial in adult patients with chordomas (CH) and chondrosarcomas (CSA) of the skull base (SB) and cervical spine (CS) enrolled 105 patients between February 1987 and April 1993. Median patient age was 41 y (18-79 y). There were 55 males and 50 females. 56 patients had CH, and 49 had CSA. 93 patients had SB tumors (89%) and 12 (11%) had CS tumors. Median follow-up was 16.7 y (range 4.5 - 20.3 y). Proton treatment was given at the Harvard Cyclotron Laboratory in Cambridge, MA. #30% of the dose was given with photons at MGH. Daily dose was 1.92 CGE (CGE = proton Gy x RBE 1.1), and 1.8 Gy for protons and photons, respectively. Patients were randomized to either a lower dose (70.2 CGE, LD) or a higher dose (76 CGE, HD) in 37 or 40 fractions, respectively. The defined tumor volume received a non-homogeneous dose in all patients, since dose constraints for adjacent critical structures were lower then the prescribed tumor dose. End points were patient survival and tumor progression by imaging studies or histology. Results: Fifty patients died, with median overall survival being 15.1 y. Overall survival for all patients at 5, 10, and 15 y was 81%, 61%, and 57% for the LD group, and 81%, 55%, and 45% for the HD group, respectively (p = 0.465). There were 23 deaths in the LD group, occurring between 7 m and 15.1 y. Median survival was not reached in the LD group. The 27 deaths in the HD group occurred at a median time of 10.5 y (5 m - 13.6 y). Treatment failure was documented in 55 patients, 25 in the LD and 30 in the HD groups. Median time to failure was 11.9 y (5 m - 15.1 y) in all patients, and was 16.8 y in the LD and 9.0 y in the HD group. Except for improved failure-free survival (FFS) in LD CSA SB patients relative to HD CSA SB patients (FFS at 5, 10, and 15 y was 94%,
S104
Volume 72, Number 1, Supplement, 2008
immediately after treatment. Two of the 5 subscales, pain/discomfort and usual activity, had a significant trend in increasing reported level 3 but the absolute number of patients reporting this level of problems was approximately #5%. Conclusions: This study of EQ-5D is unique in demonstrating very high levels of overall quality of life in patients treated with breast-conserving surgery and radiation even up to 15 years after treatment. These mean health states are comparable to those reported for the general adult U.S. population. Author Disclosure: G.M. Freedman, None; P.R. Anderson, None; T. Li, None; N. Nicolaou, None; A. Konski, None.
230
Long-term Quality of Life after Chemoradiation for Anal Cancer
P. Das, S. B. Cantor, C. L. Parker, J. B. Zampieri, A. Baschnagel, C. Eng, M. E. Delclos, S. Krishnan, N. A. Janjan, C. H. Crane U.T. M.D. Anderson Cancer Center, Houston, TX Purpose/Objective(s): Our objective was to evaluate long-term quality of life in patients treated with definitive chemoradiation for anal cancer. Materials/Methods: The study population included patients treated with definitive chemoradiation for squamous cell anal carcinoma between January 1993 and December 2003, with a minimum of 2-year follow-up after completion of chemoradiation, who were alive at the time of the study, had verifiable mailing addresses, and could speak English. Eligible subjects (n = 80) were mailed a questionnaire that included the Functional Assessment of Cancer Therapy-Colorectal (FACT-C), a 34-item instrument having a maximum score of 136, with higher scores indicating better quality of life. The questionnaire also included the Medical Outcomes Study (MOS) Sexual Problems Scale, a 4-item instrument having a maximum score of 100, with higher scores indicating worse sexual function. Furthermore, the questionnaire had 13 questions on demographic characteristics and co-morbidities. Results: Of the eligible subjects, 32 (40%) provided informed consent and completed the questionnaire. There were no significant differences in clinical and demographic characteristics between the respondents and non-respondents. Among the 32 respondents, the median dose of radiotherapy was 55 Gy (range 39.6-59.4 Gy), 72% had received concurrent 5-fluorouracil and cisplatin, 19% had received concurrent capecitabine and cisplatin, and 6% had received concurrent 5-fluorouracil and mitomycin C. The median interval between chemoradiation and survey participation was 5 years (range 3-13 years). The median total FACT-C score was 108 (range 47-128), out of a maximum (best possible) score of 136. Patients who reported depression or anxiety had significantly lower total FACT-C scores than those who did not report depression or anxiety (median score 92 vs. 109, p = 0.006). Patients with age \51 years at the time of treatment had significantly lower total FACT-C scores than those with age $51 years (median score 106 vs. 114, p = 0.033). The median score on the physical, social/family, emotional, functional, and colorectal subscales of FACT-C was 20, 23, 21, 22, and 21, out of maximum (best possible) score of 28, 28, 24, 28, and 28, respectively. The median score on the MOS sexual functioning scale was 67 (range 0-100), out of a maximum (worst possible) score of 100. Conclusions: Patients treated with chemoradiation for anal cancer reported acceptable overall quality of life scores, but poor sexual functioning scores. Investigations are warranted into treatment techniques that could reduce sexual morbidity, such as intensity modulated radiation therapy (IMRT) to spare genitalia. Author Disclosure: P. Das, None; S.B. Cantor, None; C.L. Parker, None; J.B. Zampieri, None; A. Baschnagel, None; C. Eng, None; M.E. Delclos, None; S. Krishnan, None; N.A. Janjan, None; C.H. Crane, None.
231
WITHDRAWN
232
Long-term Results of a Dose Searching Trial in Chordomas and Chondrosarcomas of the Skull Base and Cervical Spine
J. E. Munzenrider1,2, B. Y. Yeap1, T. F. DeLaney1, L. Marucci3, M. M. Fitzek4, S. E. Dean1, N. J. Liebsch1 1 Massachusetts General Hospital, Boston, MA, 2Harvard Medical School, Boston, MA, 3Regina Elena National Cancer Institute, Rome, Italy, 4Midwest Proton Therapy Center, Bloomington, IN
Purpose/Objective(s): To report a prospective randomized Phase I/II dose searching trial in adult patients with chordomas and chondrosarcomas of the skull base and cervical spine treated with high dose, 3D-conformal fractionated proton-photon therapy. Materials/Methods: A prospective randomized Phase I/II dose searching trial in adult patients with chordomas (CH) and chondrosarcomas (CSA) of the skull base (SB) and cervical spine (CS) enrolled 105 patients between February 1987 and April 1993. Median patient age was 41 y (18-79 y). There were 55 males and 50 females. 56 patients had CH, and 49 had CSA. 93 patients had SB tumors (89%) and 12 (11%) had CS tumors. Median follow-up was 16.7 y (range 4.5 - 20.3 y). Proton treatment was given at the Harvard Cyclotron Laboratory in Cambridge, MA. #30% of the dose was given with photons at MGH. Daily dose was 1.92 CGE (CGE = proton Gy x RBE 1.1), and 1.8 Gy for protons and photons, respectively. Patients were randomized to either a lower dose (70.2 CGE, LD) or a higher dose (76 CGE, HD) in 37 or 40 fractions, respectively. The defined tumor volume received a non-homogeneous dose in all patients, since dose constraints for adjacent critical structures were lower then the prescribed tumor dose. End points were patient survival and tumor progression by imaging studies or histology. Results: Fifty patients died, with median overall survival being 15.1 y. Overall survival for all patients at 5, 10, and 15 y was 81%, 61%, and 57% for the LD group, and 81%, 55%, and 45% for the HD group, respectively (p = 0.465). There were 23 deaths in the LD group, occurring between 7 m and 15.1 y. Median survival was not reached in the LD group. The 27 deaths in the HD group occurred at a median time of 10.5 y (5 m - 13.6 y). Treatment failure was documented in 55 patients, 25 in the LD and 30 in the HD groups. Median time to failure was 11.9 y (5 m - 15.1 y) in all patients, and was 16.8 y in the LD and 9.0 y in the HD group. Except for improved failure-free survival (FFS) in LD CSA SB patients relative to HD CSA SB patients (FFS at 5, 10, and 15 y was 94%,