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A Phase II Study of Intensity Modulated Radiation Therapy (IMRT) with Chemotherapy for Locoregionally Advanced Nasopharyngeal Cancer (NPC) (JCOG1015): Acute Toxicity and Treatment Compliance
E334
International Journal of Radiation Oncology Biology Physics
T. Toshiyasu,11 Y. Ota,12 K. Ishikawa,1 H. Shimizu,2 T. Minemura,13 S. Ishikura,14 T. Shibata,15 K. Nakamura,16 T. Shibata,17 and M. Hiraoka18; 1 Kinki University Faculty of Medicine, Osaka-Sayama, Japan, 2Aichi Cancer Center Hospital, Nagoya, Japan, 3National Cancer Center Hospital, Tokyo, Japan, 4Hokkaido University Hospital, Sapporo, Japan, 5 Department of Radiation Oncology, Hiroshima University Hospital, Hiroshima, Japan, 6Department of Radiation Oncology, Gunma University Graduate School of Medicine, Maebashi, Japan, 7National Cancer Center Hospital East, Division of Radiation Oncology and Particle Therapy, Kashiwa, Japan, 8Sapporo Medical University, Sapporo, Japan, 9Kyoto University Graduate School of Medicine, Kyoto 606-8507, Japan, 10Osaka Medical Center for Cancer and Cardiovascular Diseases, Osaka City, Japan, 11The Cancer Institute Hospital of Japanese Foundation for Cancer Research (JFCR), Tokyo 135-8550, Japan, 12Hyogo Cancer Center, Akashi, Japan, 13National Cancer Center, Tokyo, Japan, 14Japan Clinical Oncology Group - Radiotherapy Committee, Tokyo, Japan, 15Kagawa University Hospital, Kagawa, Japan, 16JCOG Data Center/Operations Office, National Cancer Center, Tokyo, Japan, 17Center for Research Administration and Support, National Cancer Center, Tokyo, Japan, 18 Department of Radiation Oncology and Image-applied Therapy, Kyoto University Graduate School of Medicine, Kyoto, Japan
None. K. Tsuchiya: None. Y. Murakami: None. J. Saitoh: None. T. Akimoto: None. K. Nakata: None. M. Yoshimura: None. T. Teshima: None. T. Toshiyasu: None. Y. Ota: None. K. Ishikawa: None. H. Shimizu: None. T. Minemura: None. S. Ishikura: None. T. Shibata: None. K. Nakamura: None. T. Shibata: None. M. Hiraoka: Top of the group; Japan Clinical Oncology Group.
Purpose/Objective(s): A phase II study of IMRT with chemotherapy for loco-regionally advanced NPC (JCOG1015, UMIN-CTR: UMIN000005448) was conducted to evaluate the efficacy and safety. To avoid the risk of dose distribution changes during IMRT of 7-8 weeks, we adopted adaptive two-step IMRT method. Materials/Methods: Patients (pts) aged 20-75 years with stages II-IVB NPC with performance status of 0-1 were enrolled. For all pts, computed tomography planning was done twice before the start of IMRT for initial plan of 46 Gy/23 fractions and at the third or fourth week of treatment for boost plan of 24 Gy/12 fractions to high risk CTV. A total radiation dose was 70 Gy/ 35 fractions. Chemotherapy (cisplatin 80 mg/ m2 /3-weeks 3 cycles) was given concurrently with IMRT, followed by adjuvant chemotherapy (cisplatin 70 mg/ m2 with 5-FU 700 mg/m2 for 5 days 3 cycles). The primary endpoint was 3-year overall survival (OS) and the primary analysis is planned in 2017. The planned sample size was set as 75 pts. In this preliminary report, we present the proportions of treatment completion and acute adverse events including xerostomia graded based on CTCAE v 4.0 at 1 year. Results: From April 2011 to October 2014, 75 pts were enrolled from 12 institutions. The pts consisted of 60 men and 15 women with the median age of 55 years (range, 28-75). Distribution of clinical stage was as follows: stage II, 16 (21%); stage III, 33 (44%); stage IVA or IVB, 26 (35%). Seventy-four pts completed at least 2 cycles of concurrent chemotherapy with a total dose of 70 Gy; the completion proportion of chemo-radiation therapy was 99% (95% CI; 93%-100%). The median overall treatment time for the 74 pts was 51 days (range 47-57). However, adjuvant chemotherapy was not given for 13 pts mostly due to acute toxicities or pts refusal, and it was terminated before its third cycles for 22 pts. For the remaining 39 pts (52%; 95% CI [40%-64%]), the protocol treatment was completed. Respective proportions of major grade 3-4 acute toxicities within 180 days after the start of treatment were 47% for white blood cell decrease, 29% for neutrophil count decrease, 56% for pharyngeal mucositis, 47% for oral mucositis, and 41% for dysphagia. Although 61 pts (81%) showed grade 3-4 non-hematological toxicities, only 9 pts (12%) showed grade 4 non-hematological toxicities. Grade 2 or more xerostomia was noted in 18 pts (26%) of 70 pts evaluated at 1 year after start of IMRT. Conclusion: The completion proportion of concurrent chemo-radiation therapy using adaptive two-step IMRT for NPC was high, although 3 cycles of adjuvant chemotherapy were given for only half of the pts. Acute toxicities were acceptable, and the incidence of xerostomia at 1 year was satisfactorily low. Author Disclosure: Y. Nishimura: Research Grant; Japan Agency for Medical Research and Development, AMED. top of the society; Japanese Society of Radiation Oncology (JASTRO). T. Kodaira: None. Y. Ito:
2821 Reducing Emergency Room Visits and Unplanned Hospital Admissions During Radiation Therapy in Patients With Head and Neck Cancer B.S. Chera,1 A. Yechoor,2 L. Stravers,1 J. Camporeale,2 M.E. Fleming,2 L. Terzo,1 M. Troxler,3 E. Roth,3 X. Tan,2 L. Mazur,1 L. Brown,2 M. Pignone,2 and L.B. Marks4; 1UNC School of Medicine, Chapel Hill, NC, 2University of North Carolina School of Medicine, Chapel Hill, NC, 3 University of North Carolina Hospitals, Chapel Hill, NC, 4UNC Lineberger Comprehensive Cancer Center, University of North Carolina School of Medicine, Chapel Hill, NC Purpose/Objective(s): Multimodality head and neck cancer (HNC) treatment often causes severe acute toxicities leading to high rates of emergency room (ER) visits and unplanned hospital admissions (18% and 21%, respectively in our historical experience). We conducted a quality improvement initiative aimed to reduce ER visits and unplanned inpatient admissions in patients with HNC. Materials/Methods: We created a weekly nurse/nurse practitioner-led symptom management clinic for patients with HNC receiving radiation therapy deemed at high risk for an ER visit and unplanned hospital admission (e.g. due to the receipt of concurrent chemotherapy). This was in addition to their routine weekly physician visit. Nurse or nurse practitioner independently evaluated and managed patients and involved higherlevel providers only when medically necessary. Primary quality metrics assessed were the rate of ER visits and unplanned hospitalization during and within 90 days of finishing radiation. Time to event actuarial analysis and log-rank tests (two-tailed) were performed to compare the observed rates of both ER visits and unplanned admissions to historical rates. Univariate analysis was performed to assess associations between clinical covariates and emergency room visits and unplanned admissions. We also formally surveyed to the nurses/nurse practitioners to assess their perceptions of the initiative. Results: From August 2014 to June 2015, 97 patients with HNC received a curative course of radiation and the rates of ER visits and unplanned admission were 11% (11/97) and 16% (16/97) respectively. Comparison to the historical ER visit rate of 18% and unplanned admission rate of 21% was non-significant (P Z 0.2 and P Z 0.3). Sixty-nine of the 97 patients (77%) were considered high risk for admission, and 49 (51%) were seen an average of 3.5 (range 0-7) in the symptom management clinic. Ten of these 69 (14%) patients had ER visits, and 14 (20%) had unplanned admissions. Emergency room visit and unplanned admissions rates for high-risk patients in our historical experience were 23% and 27% respectively. Comparisons of rates in high-risk patients in historical and contemporary data were non-significant: ER visits 23% vs. 14% (P Z 0.2) and unplanned admissions 27% vs. 20% (P Z 0.3). Receipt of chemotherapy did not correlate with occurrence of ER visit (P Z 0.6) but did correlate with unplanned admission (P Z 0.0006). Having more symptom management clinical visits marginally correlated with reduction in unplanned admission (P Z 0.07). We estimate that 6 ER visits and 4 unplanned admissions were prevented, resulting in a $176,848 reduction in healthcare expenditures. All of the of nurse/nurse practitioners (n Z 5) agreed/strongly agreed that unplanned admissions were prevented. Conclusion: The symptom management clinic may have reduced the rate of ER visits and unplanned admissions in patients with HNC, but the limited sample size hinders the statistical power. Additional work with a larger number of patients is warranted. Author Disclosure: B.S. Chera: None. A. Yechoor: None. L. Stravers: None. J. Camporeale: None. M.E. Fleming: None. L. Terzo: None. M.
International Journal of Radiation Oncology Biology Physics
T. Toshiyasu,11 Y. Ota,12 K. Ishikawa,1 H. Shimizu,2 T. Minemura,13 S. Ishikura,14 T. Shibata,15 K. Nakamura,16 T. Shibata,17 and M. Hiraoka18; 1 Kinki University Faculty of Medicine, Osaka-Sayama, Japan, 2Aichi Cancer Center Hospital, Nagoya, Japan, 3National Cancer Center Hospital, Tokyo, Japan, 4Hokkaido University Hospital, Sapporo, Japan, 5 Department of Radiation Oncology, Hiroshima University Hospital, Hiroshima, Japan, 6Department of Radiation Oncology, Gunma University Graduate School of Medicine, Maebashi, Japan, 7National Cancer Center Hospital East, Division of Radiation Oncology and Particle Therapy, Kashiwa, Japan, 8Sapporo Medical University, Sapporo, Japan, 9Kyoto University Graduate School of Medicine, Kyoto 606-8507, Japan, 10Osaka Medical Center for Cancer and Cardiovascular Diseases, Osaka City, Japan, 11The Cancer Institute Hospital of Japanese Foundation for Cancer Research (JFCR), Tokyo 135-8550, Japan, 12Hyogo Cancer Center, Akashi, Japan, 13National Cancer Center, Tokyo, Japan, 14Japan Clinical Oncology Group - Radiotherapy Committee, Tokyo, Japan, 15Kagawa University Hospital, Kagawa, Japan, 16JCOG Data Center/Operations Office, National Cancer Center, Tokyo, Japan, 17Center for Research Administration and Support, National Cancer Center, Tokyo, Japan, 18 Department of Radiation Oncology and Image-applied Therapy, Kyoto University Graduate School of Medicine, Kyoto, Japan
None. K. Tsuchiya: None. Y. Murakami: None. J. Saitoh: None. T. Akimoto: None. K. Nakata: None. M. Yoshimura: None. T. Teshima: None. T. Toshiyasu: None. Y. Ota: None. K. Ishikawa: None. H. Shimizu: None. T. Minemura: None. S. Ishikura: None. T. Shibata: None. K. Nakamura: None. T. Shibata: None. M. Hiraoka: Top of the group; Japan Clinical Oncology Group.
Purpose/Objective(s): A phase II study of IMRT with chemotherapy for loco-regionally advanced NPC (JCOG1015, UMIN-CTR: UMIN000005448) was conducted to evaluate the efficacy and safety. To avoid the risk of dose distribution changes during IMRT of 7-8 weeks, we adopted adaptive two-step IMRT method. Materials/Methods: Patients (pts) aged 20-75 years with stages II-IVB NPC with performance status of 0-1 were enrolled. For all pts, computed tomography planning was done twice before the start of IMRT for initial plan of 46 Gy/23 fractions and at the third or fourth week of treatment for boost plan of 24 Gy/12 fractions to high risk CTV. A total radiation dose was 70 Gy/ 35 fractions. Chemotherapy (cisplatin 80 mg/ m2 /3-weeks 3 cycles) was given concurrently with IMRT, followed by adjuvant chemotherapy (cisplatin 70 mg/ m2 with 5-FU 700 mg/m2 for 5 days 3 cycles). The primary endpoint was 3-year overall survival (OS) and the primary analysis is planned in 2017. The planned sample size was set as 75 pts. In this preliminary report, we present the proportions of treatment completion and acute adverse events including xerostomia graded based on CTCAE v 4.0 at 1 year. Results: From April 2011 to October 2014, 75 pts were enrolled from 12 institutions. The pts consisted of 60 men and 15 women with the median age of 55 years (range, 28-75). Distribution of clinical stage was as follows: stage II, 16 (21%); stage III, 33 (44%); stage IVA or IVB, 26 (35%). Seventy-four pts completed at least 2 cycles of concurrent chemotherapy with a total dose of 70 Gy; the completion proportion of chemo-radiation therapy was 99% (95% CI; 93%-100%). The median overall treatment time for the 74 pts was 51 days (range 47-57). However, adjuvant chemotherapy was not given for 13 pts mostly due to acute toxicities or pts refusal, and it was terminated before its third cycles for 22 pts. For the remaining 39 pts (52%; 95% CI [40%-64%]), the protocol treatment was completed. Respective proportions of major grade 3-4 acute toxicities within 180 days after the start of treatment were 47% for white blood cell decrease, 29% for neutrophil count decrease, 56% for pharyngeal mucositis, 47% for oral mucositis, and 41% for dysphagia. Although 61 pts (81%) showed grade 3-4 non-hematological toxicities, only 9 pts (12%) showed grade 4 non-hematological toxicities. Grade 2 or more xerostomia was noted in 18 pts (26%) of 70 pts evaluated at 1 year after start of IMRT. Conclusion: The completion proportion of concurrent chemo-radiation therapy using adaptive two-step IMRT for NPC was high, although 3 cycles of adjuvant chemotherapy were given for only half of the pts. Acute toxicities were acceptable, and the incidence of xerostomia at 1 year was satisfactorily low. Author Disclosure: Y. Nishimura: Research Grant; Japan Agency for Medical Research and Development, AMED. top of the society; Japanese Society of Radiation Oncology (JASTRO). T. Kodaira: None. Y. Ito:
2821 Reducing Emergency Room Visits and Unplanned Hospital Admissions During Radiation Therapy in Patients With Head and Neck Cancer B.S. Chera,1 A. Yechoor,2 L. Stravers,1 J. Camporeale,2 M.E. Fleming,2 L. Terzo,1 M. Troxler,3 E. Roth,3 X. Tan,2 L. Mazur,1 L. Brown,2 M. Pignone,2 and L.B. Marks4; 1UNC School of Medicine, Chapel Hill, NC, 2University of North Carolina School of Medicine, Chapel Hill, NC, 3 University of North Carolina Hospitals, Chapel Hill, NC, 4UNC Lineberger Comprehensive Cancer Center, University of North Carolina School of Medicine, Chapel Hill, NC Purpose/Objective(s): Multimodality head and neck cancer (HNC) treatment often causes severe acute toxicities leading to high rates of emergency room (ER) visits and unplanned hospital admissions (18% and 21%, respectively in our historical experience). We conducted a quality improvement initiative aimed to reduce ER visits and unplanned inpatient admissions in patients with HNC. Materials/Methods: We created a weekly nurse/nurse practitioner-led symptom management clinic for patients with HNC receiving radiation therapy deemed at high risk for an ER visit and unplanned hospital admission (e.g. due to the receipt of concurrent chemotherapy). This was in addition to their routine weekly physician visit. Nurse or nurse practitioner independently evaluated and managed patients and involved higherlevel providers only when medically necessary. Primary quality metrics assessed were the rate of ER visits and unplanned hospitalization during and within 90 days of finishing radiation. Time to event actuarial analysis and log-rank tests (two-tailed) were performed to compare the observed rates of both ER visits and unplanned admissions to historical rates. Univariate analysis was performed to assess associations between clinical covariates and emergency room visits and unplanned admissions. We also formally surveyed to the nurses/nurse practitioners to assess their perceptions of the initiative. Results: From August 2014 to June 2015, 97 patients with HNC received a curative course of radiation and the rates of ER visits and unplanned admission were 11% (11/97) and 16% (16/97) respectively. Comparison to the historical ER visit rate of 18% and unplanned admission rate of 21% was non-significant (P Z 0.2 and P Z 0.3). Sixty-nine of the 97 patients (77%) were considered high risk for admission, and 49 (51%) were seen an average of 3.5 (range 0-7) in the symptom management clinic. Ten of these 69 (14%) patients had ER visits, and 14 (20%) had unplanned admissions. Emergency room visit and unplanned admissions rates for high-risk patients in our historical experience were 23% and 27% respectively. Comparisons of rates in high-risk patients in historical and contemporary data were non-significant: ER visits 23% vs. 14% (P Z 0.2) and unplanned admissions 27% vs. 20% (P Z 0.3). Receipt of chemotherapy did not correlate with occurrence of ER visit (P Z 0.6) but did correlate with unplanned admission (P Z 0.0006). Having more symptom management clinical visits marginally correlated with reduction in unplanned admission (P Z 0.07). We estimate that 6 ER visits and 4 unplanned admissions were prevented, resulting in a $176,848 reduction in healthcare expenditures. All of the of nurse/nurse practitioners (n Z 5) agreed/strongly agreed that unplanned admissions were prevented. Conclusion: The symptom management clinic may have reduced the rate of ER visits and unplanned admissions in patients with HNC, but the limited sample size hinders the statistical power. Additional work with a larger number of patients is warranted. Author Disclosure: B.S. Chera: None. A. Yechoor: None. L. Stravers: None. J. Camporeale: None. M.E. Fleming: None. L. Terzo: None. M.