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Complete pathological response after preoperative chemotherapy for locally advanced rectal cancer: a case report
abstracts
Annals of Oncology
P1 267
Cost-effectiveness of pegfilgrastim in prostate cancer patients receiving cabazitaxel
Yu Kondo, Takayoshi Sakakibara, Misato Furuta, Izumi Hiraiwa, Jun Kato, Aki Kato, Yoshio Miyake Department of Pharmacy, Toyota Kosei Hospital Background: Cabazitaxel plus predonisolone is used to treat castration-resistant prostate cancer but has a high risk of inducing febrile neutropenia (FN). While pegfilgrastim (Peg-G) is used for prophylaxis of FN, no cost-efficacy analysis has been conducted, despite its substantial expense. The objective this study was to evaluate the cost-effectiveness of Peg-G in patients receiving cabazitaxel. Methods: We simulated model patients receiving cabazitaxel and developed a decisionanalytical model of patients receiving Peg-G or no prophylaxis (no-G). The costs, probabilities and incremental cost-effectiveness ratio (ICER) of each treatment were calculated from the health insurers’ perspective, and the threshold ICER was set at 6,000,000 JPY per quality-adjusted life-year (QALY). In the base analysis, the cost of Peg-G was set at 106,660 JPY. The probabilities, utility score and other costs were obtained from published sources. The robustness of this model was validated by a one-way sensitivity analysis and probabilistic sensitivity analysis. Results: The ICER was calculated to be 9,276,805 JPY per QALY, which was above the threshold. In the one-way sensitivity analysis, if the cost of Peg-G exceeded 97,237 JPY, the ICER fell below the threshold. The probabilistic sensitivity analysis revealed a 50.0% probability that Peg-G was cost-effective compared with no-G. Conclusion: Peg-G was not cost-effective compared with no-G. However, if the cost of Peg-G could be reduced below 97,237 JPY, Peg-G would become cost-effective compared with no-G.
markedly decreased and all lymph nodes metastasis had disappeared. Therefore, the patient underwent conventional resection of rectum with D3 lymph node dissection and closure of colostomy. The histopathological analysis of the specimen revealed that all lesions were fibrotic, devoid of any viable cancer cells. Thus, this lesion was assigned a final classification of ypT0N0M0 stage 0 according to the 8th UICC guidelines. Conclusions: We present a rare case with complete pathological response of conversion surgery with combination treatment including mFOLFOX6 plus bevacizumab and radical surgery.
P2 025
Down-staging and histological effects might be predictive factors for DOC1CDDP15-FU for esophageal cancer
Kazuma Kobayashi, Kengo Kanetaka, Akira Yoneda, Shinichiro Kobayashi, Shun Yamaguchi, Hanako Tetsuo, Satomi Okada, Takahiro Enjoji, Sayaka Kuba, Chika Sakimura, Taiichiro Kosaka, Yuusuke Inoue, Shinichiro Ono, Koji Natsuda, Tomohiko Adachi, Masaaki Hidaka, Yasuhiro Torashima, Shinichiro Ito, Kosho Yamanouchi, Mitsuhisa Takatsuki, Susumu Eguchi Department of Surgery, Nagasaki University Graduate School of Biomedical Sciences Background: In Japan, two courses of CDDPþ5-FU (CF) therapy followed by surgery is accepted as a standard treatment for stage II/III esophageal cancer (EC) based on the results of the JCOG9907 trial. However, in some cases, especially stage III disease, the anti-tumor effect of CF is insufficient. Therefore, a three-arm phase III trial (neoadjuvant [NAC] setting: CF vs. CFþradiation vs. DOCþCF [DCF]) is on-going. We have aggressively performed DCF therapy mainly in NAC settings since October 2014. We herein review the outcomes of DCF therapy. Methods: Twenty-three patients (20 men, 3 women; median age: 70.0 years) with stage III or IV EC who received DCF therapy (October 2014 to February 2018) were retrospectively reviewed. Results: The response rate was 43.5%. Down-staging was achieved in 11 patients (47.8%) over the course of treatment. Twenty-one patients transited to surgery, and 20 of them underwent R0 resection. One patient with disease progression was converted to chemoradiation therapy. Histological efficacy was observed in 21 patients, including 7 cases of grade 2. Those treated with DCF therapy who achieved down-staging had a significantly longer relapse-free survival (RFS) than those without down-staging (median RFS: not reached vs. 167 days, p ¼ 0.0011) and also tended to have a longer overall survival (OS) than those without down-staging (MST: not reached vs. 824 days, p ¼ 0.0637). Patients receiving CF therapy with down-staging tended to show a better RFS and OS than those without down-staging, although not to a significant degree. Patients receiving DCF therapy with grade 1b histological efficacy tended to have a longer RFS than those with grade <1b (median RFS: 1011 vs. 175 days). However, the RFS of stage III patients receiving CF therapy was not correlated with the histological efficacy. Conclusions: These findings suggest that down-staging and the histological efficacy might be predictive factors for DCF therapy for EC.
P2 027
Impact of chemotherapy on overall survival and hospitalization in elderly patients with gastric cancer
Yasuko Murakawa, Masato Sakayori, Kazunori Otsuka Medical Oncology Department, Miyagi Cancer Center P1 288
Complete pathological response after preoperative chemotherapy for locally advanced rectal cancer: a case report
Ryoichi Miyamoto1, Kazunori Kikuchi2, Atsushi Uchida2, Masayoshi Ozawa2, Michihiro Maeda1, Naoki Sano1, Sosuke Tadano1, Satoshi Inagawa1, Tatsuya Oda3, Nobuhiro Ohkohchi3 1 Department of Gastroenterological Surgery, Tsukuba Medical Center Hospital, 2 Department of Pathology, Tsukuba Medical Center Hospital, 3Department of Surgery, Division of Gastroenterological and Hepatobiliary Surgery and Organ Transplantation, University of Tsukuba Background: For locally advanced rectal cancer in Japan, radical surgery including lateral lymph node dissection followed by postoperative chemotherapy is the standard treatment. However, with regard to preoperative chemotherapy for locally advanced rectal cancer, its significance and efficacy remains controversial. The present study reported the apparent effectiveness with complete pathological response of conversion surgery including mFOLFOX6 plus bevacizumab and radical surgery. Additionally, we review the relevant literature and discuss the clinical management including preoperative chemotherapy for locally advanced rectal cancer. Case presentation: A 59-year-old male presented with severe constipation, bloody stool and loss of 10 % of body weight over 3 month. Preoperative examination revealed locally advanced rectum cancer with extensive invasion of bladder wall and regional enlarged lymph nodes. Thus, this lesion was assigned a preoperative classification of T4bN2bM0 stage IIIC according to the 8th Union for International Cancer Control (UICC) guidelines. Therefore, the patient initially underwent external loop colostomy with transverse colon. Next the patient received the chemotherapy including mFOLFOX6 plus bevacizumab. After 12 course of chemotherapy, the tumor size was
Volume 30 | Supplement 6 | October 2019
Background: Research on chemotherapy (CT) for elderly patients with cancer is currently being performed. We studied how CT affects overall survival (OS) and hospitalization length/incidence in elderly patients with incurable gastric cancer. Methods: We retrospectively evaluated patients with incurable gastric cancer at Miyagi Cancer Center from May 2014 to February 2018. Patient characteristics, clinical courses, and prognoses were analyzed using logistic regression, multivariate Cox regression, and scatter plot analyses and the KaplanMeier Method. Results: We included 67 men and 29 women; 21 and 75 patients were aged 75 and <75 years, respectively. Most patients had good Eastern Cooperative Oncology Group (ECOG) performance status (PS) (02 [n ¼ 77] and 34 [n ¼ 19]). CT was performed in 77(80.2%) patients; 19(19.8%) received best supportive care (BSC). Caregivers were the first or second degree of kinship (n ¼ 86 and 7, respectively) or others(n ¼ 3). More patients aged 75 years chose BSC than those aged <75 years (BSC [CT]:9[12] vs.10[65]; p<0.05). Age did not affect sex, ECOG PS, or caregiver type. We observed similar outcomes in patients aged 75 and <75 years with CT (median OS:12.2 vs.13.8 months; p¼0.376). ECOG PS 02 was significantly and independently associated with longer OS compared with ECOG PS 34(p<0.001). CT was significantly and independently associated with longer OS than BSC(p<0.001). Age, sex, and caregiver type were not associated with longer OS. CT endtodeath periods were longer in patients aged 75 years than in those aged <75 years(6.1 vs. 2.7 months; p<0.001). Hospitalization incidences were greater in patients aged <75 years with PS 02 who received CT. Conclusion: Patients aged 75 years had better outcomes, like in those aged <75 years who received CT. Longer CT endtodeath periods and fewer hospitalizations were observed in patients aged 75 years than in those aged <75 years.
doi:10.1093/annonc/mdz343 | vi129
Downloaded from https://academic.oup.com/annonc/article-abstract/30/Supplement_6/mdz343.052/5582984 by guest on 24 October 2019
regularly hold workshop (WS) to realize high-performance team in which the hospital and community are linked. The objective of this study is to clarify the challenges of WS format and facilitator training. Methods: In May 2018, we conducted 14.75 hours of WS (lecture þ group work [GW] þ presentation) on 2 days. In the GW, participants were separated into 4 groups then discussed about ideal medical care on 1 case each. At last, case discussions were presented. The WS participants were asked 2 questionnaires before and after WS. The facilitators conducted WS after the preliminary training then answered 1 questionnaire. Results: Of the 45 participants, doctors/ nurses/ pharmacists/ other medical professions (including medical social worker, nutritionist, and physiologist)/ survivors were 18/ 42/ 16/ 20/ 4%, respectively. Twenty-six (58%) of participants expected to improve communication skills. Expecting content was facilitator/ GW/ lecture (76/ 67/ 64%) in order. Percentage of satisfaction after WS of high/ moderate/ low/ no answer was overall: 80/ 13/ 0/ 7%, lecture: 78/ 15/ 0/ 7%, GW: 69/ 20/ 0/ 11%, and facilitator: 73/ 20/ 0/ 7%. Twelve facilitators consisted of 4 physicians/ nurses/ pharmacists were assigned to each of the 4 groups. All 9 facilitators who joined the preliminary training (100%) responded that the training was useful. Of 12 facilitators, the mean percentage who felt "achieved" was 77% on "Human Needs-aware support", and 50% on "Task Needsaware support" and "appropriate intervention", respectively. Conclusion: In WS, expectations by participants for facilitators as well as lectures and GW were high, and pre-WS facilitator training is necessary. Establishing the way to train communication skills is a future challenge.
Annals of Oncology
P1 267
Cost-effectiveness of pegfilgrastim in prostate cancer patients receiving cabazitaxel
Yu Kondo, Takayoshi Sakakibara, Misato Furuta, Izumi Hiraiwa, Jun Kato, Aki Kato, Yoshio Miyake Department of Pharmacy, Toyota Kosei Hospital Background: Cabazitaxel plus predonisolone is used to treat castration-resistant prostate cancer but has a high risk of inducing febrile neutropenia (FN). While pegfilgrastim (Peg-G) is used for prophylaxis of FN, no cost-efficacy analysis has been conducted, despite its substantial expense. The objective this study was to evaluate the cost-effectiveness of Peg-G in patients receiving cabazitaxel. Methods: We simulated model patients receiving cabazitaxel and developed a decisionanalytical model of patients receiving Peg-G or no prophylaxis (no-G). The costs, probabilities and incremental cost-effectiveness ratio (ICER) of each treatment were calculated from the health insurers’ perspective, and the threshold ICER was set at 6,000,000 JPY per quality-adjusted life-year (QALY). In the base analysis, the cost of Peg-G was set at 106,660 JPY. The probabilities, utility score and other costs were obtained from published sources. The robustness of this model was validated by a one-way sensitivity analysis and probabilistic sensitivity analysis. Results: The ICER was calculated to be 9,276,805 JPY per QALY, which was above the threshold. In the one-way sensitivity analysis, if the cost of Peg-G exceeded 97,237 JPY, the ICER fell below the threshold. The probabilistic sensitivity analysis revealed a 50.0% probability that Peg-G was cost-effective compared with no-G. Conclusion: Peg-G was not cost-effective compared with no-G. However, if the cost of Peg-G could be reduced below 97,237 JPY, Peg-G would become cost-effective compared with no-G.
markedly decreased and all lymph nodes metastasis had disappeared. Therefore, the patient underwent conventional resection of rectum with D3 lymph node dissection and closure of colostomy. The histopathological analysis of the specimen revealed that all lesions were fibrotic, devoid of any viable cancer cells. Thus, this lesion was assigned a final classification of ypT0N0M0 stage 0 according to the 8th UICC guidelines. Conclusions: We present a rare case with complete pathological response of conversion surgery with combination treatment including mFOLFOX6 plus bevacizumab and radical surgery.
P2 025
Down-staging and histological effects might be predictive factors for DOC1CDDP15-FU for esophageal cancer
Kazuma Kobayashi, Kengo Kanetaka, Akira Yoneda, Shinichiro Kobayashi, Shun Yamaguchi, Hanako Tetsuo, Satomi Okada, Takahiro Enjoji, Sayaka Kuba, Chika Sakimura, Taiichiro Kosaka, Yuusuke Inoue, Shinichiro Ono, Koji Natsuda, Tomohiko Adachi, Masaaki Hidaka, Yasuhiro Torashima, Shinichiro Ito, Kosho Yamanouchi, Mitsuhisa Takatsuki, Susumu Eguchi Department of Surgery, Nagasaki University Graduate School of Biomedical Sciences Background: In Japan, two courses of CDDPþ5-FU (CF) therapy followed by surgery is accepted as a standard treatment for stage II/III esophageal cancer (EC) based on the results of the JCOG9907 trial. However, in some cases, especially stage III disease, the anti-tumor effect of CF is insufficient. Therefore, a three-arm phase III trial (neoadjuvant [NAC] setting: CF vs. CFþradiation vs. DOCþCF [DCF]) is on-going. We have aggressively performed DCF therapy mainly in NAC settings since October 2014. We herein review the outcomes of DCF therapy. Methods: Twenty-three patients (20 men, 3 women; median age: 70.0 years) with stage III or IV EC who received DCF therapy (October 2014 to February 2018) were retrospectively reviewed. Results: The response rate was 43.5%. Down-staging was achieved in 11 patients (47.8%) over the course of treatment. Twenty-one patients transited to surgery, and 20 of them underwent R0 resection. One patient with disease progression was converted to chemoradiation therapy. Histological efficacy was observed in 21 patients, including 7 cases of grade 2. Those treated with DCF therapy who achieved down-staging had a significantly longer relapse-free survival (RFS) than those without down-staging (median RFS: not reached vs. 167 days, p ¼ 0.0011) and also tended to have a longer overall survival (OS) than those without down-staging (MST: not reached vs. 824 days, p ¼ 0.0637). Patients receiving CF therapy with down-staging tended to show a better RFS and OS than those without down-staging, although not to a significant degree. Patients receiving DCF therapy with grade 1b histological efficacy tended to have a longer RFS than those with grade <1b (median RFS: 1011 vs. 175 days). However, the RFS of stage III patients receiving CF therapy was not correlated with the histological efficacy. Conclusions: These findings suggest that down-staging and the histological efficacy might be predictive factors for DCF therapy for EC.
P2 027
Impact of chemotherapy on overall survival and hospitalization in elderly patients with gastric cancer
Yasuko Murakawa, Masato Sakayori, Kazunori Otsuka Medical Oncology Department, Miyagi Cancer Center P1 288
Complete pathological response after preoperative chemotherapy for locally advanced rectal cancer: a case report
Ryoichi Miyamoto1, Kazunori Kikuchi2, Atsushi Uchida2, Masayoshi Ozawa2, Michihiro Maeda1, Naoki Sano1, Sosuke Tadano1, Satoshi Inagawa1, Tatsuya Oda3, Nobuhiro Ohkohchi3 1 Department of Gastroenterological Surgery, Tsukuba Medical Center Hospital, 2 Department of Pathology, Tsukuba Medical Center Hospital, 3Department of Surgery, Division of Gastroenterological and Hepatobiliary Surgery and Organ Transplantation, University of Tsukuba Background: For locally advanced rectal cancer in Japan, radical surgery including lateral lymph node dissection followed by postoperative chemotherapy is the standard treatment. However, with regard to preoperative chemotherapy for locally advanced rectal cancer, its significance and efficacy remains controversial. The present study reported the apparent effectiveness with complete pathological response of conversion surgery including mFOLFOX6 plus bevacizumab and radical surgery. Additionally, we review the relevant literature and discuss the clinical management including preoperative chemotherapy for locally advanced rectal cancer. Case presentation: A 59-year-old male presented with severe constipation, bloody stool and loss of 10 % of body weight over 3 month. Preoperative examination revealed locally advanced rectum cancer with extensive invasion of bladder wall and regional enlarged lymph nodes. Thus, this lesion was assigned a preoperative classification of T4bN2bM0 stage IIIC according to the 8th Union for International Cancer Control (UICC) guidelines. Therefore, the patient initially underwent external loop colostomy with transverse colon. Next the patient received the chemotherapy including mFOLFOX6 plus bevacizumab. After 12 course of chemotherapy, the tumor size was
Volume 30 | Supplement 6 | October 2019
Background: Research on chemotherapy (CT) for elderly patients with cancer is currently being performed. We studied how CT affects overall survival (OS) and hospitalization length/incidence in elderly patients with incurable gastric cancer. Methods: We retrospectively evaluated patients with incurable gastric cancer at Miyagi Cancer Center from May 2014 to February 2018. Patient characteristics, clinical courses, and prognoses were analyzed using logistic regression, multivariate Cox regression, and scatter plot analyses and the KaplanMeier Method. Results: We included 67 men and 29 women; 21 and 75 patients were aged 75 and <75 years, respectively. Most patients had good Eastern Cooperative Oncology Group (ECOG) performance status (PS) (02 [n ¼ 77] and 34 [n ¼ 19]). CT was performed in 77(80.2%) patients; 19(19.8%) received best supportive care (BSC). Caregivers were the first or second degree of kinship (n ¼ 86 and 7, respectively) or others(n ¼ 3). More patients aged 75 years chose BSC than those aged <75 years (BSC [CT]:9[12] vs.10[65]; p<0.05). Age did not affect sex, ECOG PS, or caregiver type. We observed similar outcomes in patients aged 75 and <75 years with CT (median OS:12.2 vs.13.8 months; p¼0.376). ECOG PS 02 was significantly and independently associated with longer OS compared with ECOG PS 34(p<0.001). CT was significantly and independently associated with longer OS than BSC(p<0.001). Age, sex, and caregiver type were not associated with longer OS. CT endtodeath periods were longer in patients aged 75 years than in those aged <75 years(6.1 vs. 2.7 months; p<0.001). Hospitalization incidences were greater in patients aged <75 years with PS 02 who received CT. Conclusion: Patients aged 75 years had better outcomes, like in those aged <75 years who received CT. Longer CT endtodeath periods and fewer hospitalizations were observed in patients aged 75 years than in those aged <75 years.
doi:10.1093/annonc/mdz343 | vi129
Downloaded from https://academic.oup.com/annonc/article-abstract/30/Supplement_6/mdz343.052/5582984 by guest on 24 October 2019
regularly hold workshop (WS) to realize high-performance team in which the hospital and community are linked. The objective of this study is to clarify the challenges of WS format and facilitator training. Methods: In May 2018, we conducted 14.75 hours of WS (lecture þ group work [GW] þ presentation) on 2 days. In the GW, participants were separated into 4 groups then discussed about ideal medical care on 1 case each. At last, case discussions were presented. The WS participants were asked 2 questionnaires before and after WS. The facilitators conducted WS after the preliminary training then answered 1 questionnaire. Results: Of the 45 participants, doctors/ nurses/ pharmacists/ other medical professions (including medical social worker, nutritionist, and physiologist)/ survivors were 18/ 42/ 16/ 20/ 4%, respectively. Twenty-six (58%) of participants expected to improve communication skills. Expecting content was facilitator/ GW/ lecture (76/ 67/ 64%) in order. Percentage of satisfaction after WS of high/ moderate/ low/ no answer was overall: 80/ 13/ 0/ 7%, lecture: 78/ 15/ 0/ 7%, GW: 69/ 20/ 0/ 11%, and facilitator: 73/ 20/ 0/ 7%. Twelve facilitators consisted of 4 physicians/ nurses/ pharmacists were assigned to each of the 4 groups. All 9 facilitators who joined the preliminary training (100%) responded that the training was useful. Of 12 facilitators, the mean percentage who felt "achieved" was 77% on "Human Needs-aware support", and 50% on "Task Needsaware support" and "appropriate intervention", respectively. Conclusion: In WS, expectations by participants for facilitators as well as lectures and GW were high, and pre-WS facilitator training is necessary. Establishing the way to train communication skills is a future challenge.