FNCA 2017 Workshop on Radiation Oncology Project
October 25-28, 2017
Manila, the Philippines
(1) Following the agreement at the 18th Forum for Nuclear Cooperation in Asia (FNCA) Coordinators Meeting, the FNCA FY2017 Workshop on Radiation Oncology was held from October 25th to 28th, 2017, in Manila, the Philippines. The meeting was co-organized by Jose R. Reyes Memorial Medical Center (JRRMMC), Philippine Nuclear Research Institute (PNRI) and the Ministry of Education, Culture, Sports, Science and Technology of Japan (MEXT). Representatives from 11 FNCA member countries, namely Bangladesh, China, Indonesia, Japan, Kazakhstan, Korea, Malaysia, Mongolia, the Philippines, Thailand and Vietnam participated in the workshop.
(2) Dr. Miriam Joy Calaguas, Chairman, Department of Radiotherapy, JRRMMC moderated the session. She officially opened the workshop and reviewed the history of this project.
Dr. Soledad S. Castañeda, FNCA Coordinator of the Philippines welcomed the participants with her remarks.
Mr. Tomoaki WADA, FNCA Coordinator of Japan gave the opening address.
Prof. Shingo KATO, the Project Leader of Radiation Oncology Project gave his remarks and keynote address.
Dr. Carlo A. Arcilla, Director of Philippine Nuclear Research Institute (PNRI) gave his remarks.
Dr. Yuichi MICHIKAWA, MEXT also gave his remarks and introduced the FNCA and Human Resource Development programs implemented by the Japanese Government.
(3) Dr. Dennis V. Doromal, President of Philippines Radiation Oncology Society (PROS), delivered a special lecture on the Overview of Radiation Oncology in the Philippines. His talk covered the wide range of statistical data about cancer treatment in the Philippines.
(4) Introduction of individual participants followed.
(5) The agenda was adopted and chairpersons and rapporteurs were selected. (Annex 1)
Session 1: Phase II Study of Concurrent Chemoradiotherapy with Extended-Field Radiotherapy for Locally Advanced Cervical Cancer (CERVIX-IV)
(6) Dr. Noriyuki Okonogi, Section Chief, Gynecologic Tumor, National Institute of Radiological Science (NIRS) Hospital, National Institutes for Quantum and Radiological Science and Technology, Japan (QST), presented the protocol of Cervix IV, a Phase II Study of Concurrent Chemoradiotherapy with Extended-Field Radiotherapy for Locally Advanced Cervical Cancer.
An update on the clinical data of CERVIX-IV was presented by representatives of each participating country with the following number of patients: Bangladesh (32), China (8), Indonesia (9), Japan (20), Kazakhstan (1), Korea (7), Malaysia (5), Mongolia (8), Philippines (4), Thailand (4) and Vietnam (8). The total number of the patients was (106).
Dr. Okonogi then presented the summary of the follow-up data. As of today, a total of 106 cases were submitted for this study, 12 cases were not evaluable.
Of the 94 evaluable cases: 50 patients had stage IIB disease and 44 had stage IIIB disease. All patients had positive pelvic lymph node (PLN) and negative paraaortic lymph node (PALN) assessed by CT or USN. Median overall treatment time was 57 days. Mean dose to point A was 81.9 Gy. Seventy six (81 %) patients received > 4 cycles of chemotherapy. Grade 3 leukopenia occurred in 19 patients (20%), 1 patient developed grade 4 neutropenia. For late toxicity, sigmoid/rectum grade 3 toxicity was observed in 2 patients, small bowel grade 3 toxicity was observed in 2 patients. The 2-year follow-up rate was 97%. The 2-year and 5-year local control (LC) rates were 96% and 91%, respectively. The 2-year and 5-year progression free survival (PFS) rates were 77% and 65%, respectively. The 2-year and 5-year overall survival (OS) rates were 91% and 77%, respectively.
(7) An open discussion on the clinical data of Cervix-IV followed. The result of Cervix-IV is better than Cervix-III, patients with distant metastases decreased. On the other hand, follow-up of patients need CT. Preliminary analysis showed no difference in OS between stage IIB and IIIB. Prophylactic paraaortic lymph node irradiation showed good result without increasing toxicity.
Session 2: Prospective Observational Study of 3D-Image guided brachy therapy for Locally Advanced Cervical Cancer (CERVIX-V)
(8) Dr. OKONOGI introduced and reviewed the protocol of Cervix-V. The protocol was approved by the Institutional Review Board (IRB) in NIRS in May 2017.
(9) Each country spoke about the current preparation state, present problems and difficulties to work on CERVIX-V.
Bangladesh: 2 centers are planning to join, in one IRB was already approved, one still in preparation. Proposed the necessity of hands-on training and QC of follow-up.
China: IRB papers being prepared.
Indonesia: IRB approved in one institute, one institute pending.
Kazakhstan: IRB approved in one institute, one patient enrolled.
Korea: IRB papers under translation and due for submission. The protocol may conflict with ongoing clinical trials.
Malaysia: IRB approved in one institute.
Mongolia: 3D-IGBT not yet available, implementation project on-going.
Philippines: IRB submission revised and waiting approval.
Thailand: IRB papers under translation.
Viet Nam: IRB papers yet to be submitted.
(10) Discussion on CERVIX-V followed. The use of IMRT for whole pelvis irradiation was accepted in the trial. It was confirmed that no chemotherapy in adjuvant nor neoadjuvant setup is to be allowed and concurrent chemotherapy other than cisplatin is also not acceptable. It was also emphasized that each brachytherapy session is to be done with 3D image guidance.
(11) All member states agreed on the necessity of on-site training, but the framework was an issue. Prof. Kato proposed a framework for on-site training; conducting 3D-IGBT on-site training during FNCA WS on Radiation Oncology annual meeting.
Session 3: QA/QC for 3D-IGBT
(12) Dr. Hideyuki MIZUNO, Senior Researcher, Department of Radiation Measurement and Dose Assessment, NIRS, QST, presented plans of auditing 3D-IGBT. The following aspects were mentioned for audit: applicator commissioning, source position confirmation, and source calibration. In order to conduct these procedures, a newly designed water phantom is currently being prepared.
(13) Mr. Julius Cezar ROJALES, Senior Medical Physicist and Vice President for Ancillary Services, St. Luke’s Medical Center presented the current status of 3D-IGBT in the Philippines.
(14) Dr. Shigekazu FUKUDA, Section Manager, Radiation Quality Control Section, Clinical Research Cluster, NIRS, QST, reported the current progress of Electronic Data Capture system preparation. While some problems are yet to be fixed, website is operational and member state are encouraged to access the website and to report any difficulties.
Session 4: Phase II Study of Neoadjuvant Chemotherapy with Concurrent Chemoradiotherapy (CCRT) for Nasopharyngeal Carcinoma (NPC-III)
(15) Dr. Hirokazu MAKISHIMA, Attending Physician, Urological Tumor Section, NIRS, QST introduced the protocol of NPC-III, a Phase II Study of Neoadjuvant Chemotherapy with CCRT for Nasopharyngeal Carcinoma (NPC). Recent clinical data was presented by representatives of each participating country.
An update on the clinical data of NPC-III was presented by representatives of each participating country with the following number of patients: Bangladesh (1), China (8), Indonesia (12), Japan (0), Kazakhstan (0), Korea (0), Malaysia (25), Mongolia (0), Philippines (7) Thailand (0) and Vietnam (55). The total number of the patients was 108. New cases: 43.
(16) Dr. MAKISHIMA then presented the summary of the follow-up data.
Median follow up was 38 months (2-73). Median age was 47 years. All patients had 2 -3 cycles of neoadjuvant chemotherapy for a compliance rate of 100%, while concurrent chemotherapy had 75% compliance rate for 4 cycles or more. Median overall treatment time of radiotherapy was 55 days (range 44 - 232 days). Radiotherapy treatment interruption of >14 days occurred in 29% of patients mainly due to machine breakdown, re-planning and toxicities. In the neoadjuvant phase, grade 3/4 hematological toxicities occurred in 16% of patients and non-hematological toxicities in 22%. During the concurrent phase, grade 3/4 hematological toxicities occurred in 25% of patients and non-hematological toxicities in 34%. Late toxicities of grade 3 occurred in 10% of patients, mainly salivary gland and subcutaneous tissue toxicities.
Efficacy results: 3-year survival results: OS was 73%. Loco-regional failure was 22%. Distant metastasis free rate (DMF) was 78%. PFS was 70%. When compared with the results from NPC-I study, these results showed better rates in DMF and OS but worse rates in local control, but all of which were not statistically significant. Failure was mainly in the distant metastasis sites (17%) but this figure is lower compared to NPC-I study (28%).
The target enrolment is 120 patients and 108 were accrued so far.
As the target is nearly achieved, it was decided to continue with enrolment for one more year. The data center will communicate with participating centers closely to monitor accrual and to inform when target accrual is achieved.
Session 5: Phase II Study of Hypofractionated Radiotherapy for Breast Cancer (Postmastectomy Radiation Therapy (PMRT)/BREAST-I)
(17) Dr. Sawa KONO, Assistant Professor, Tokyo Women’s Medical University introduced and reviewed the protocol of PMRT /BREAST-I.
(18) The clinical data of Phase II Study of Postmastectomy Radiation Therapy (PMRT) was presented by representatives of each participating countries. The following number of patients were reported: Bangladesh (77), China (13), Indonesia (2), Japan (8), Kazakhstan (36), Korea (0), Malaysia (0), Mongolia (25), Philippines (10), Thailand (0) and Vietnam (0). The total number of PMRT patients were 171.
(19) Prof. Kumiko KARASAWA, Professor and Chair, Department of Radiation Oncology, School of Medicine, Tokyo Women's Medical University presented the summary of the PMRT clinical data of breast cancer cases (171).
Overall 171 patients in HF-PMRT arm were enrolled during 56 months. Evaluable number of patients was 164. All patients completed protocol treatment. The median age was 49 years old (range, 24-80). Ninety-two patients (56%) had right-sided breast cancer. The clinical stage was IIA in 65 patients (40%), IIB in 60 (37%), IIIA in 35 (21%), IIIB in 3 (2%), and IIIC in 1 (1%), respectively. The median treatment duration was 21 days (range, 16-256). Seven patients experienced treatment interruption. Acute dermatitis of grade 2 or higher was observed in 3 patients (1%) and grade 1 acute subcutaneous toxicity was observed in 16 patients (10%). Acute grade 1 cardiac toxicity was observed in 3 patients (2%) and late grade 1 cardiac toxicity in 4 patients (2%). Late grade 1 lung toxicity was observed in 11 patients (7%). Five loco-regional recurrence, 13 distant metastases and 8 breast cancer deaths had been observed.
(20) An open discussion on the clinical data followed. Some data are missing or wrongly written in the registration sheet. All co-investigators are advised to re-check their data and send corrected data. Co-investigators are encouraged to enroll patients until next year.
Session 6: Phase II Study of Hypofractionated Radiotherapy for Breast Cancer (Whole Breast Irradiation / BREAST-I)
(21) Dr. Sawa KONO introduced and reviewed the protocol of Whole Breast Irradiation (WBI) / BREAST-I.
(22) The clinical data of Phase II Study of WBI was presented by representatives of each participating countries. The following numbers were reported: Bangladesh (31), China (6), Indonesia (16), Japan (138), Kazakhstan (14), Korea (10), Malaysia (0), Mongolia (3), Philippines (0), Thailand (16) and Vietnam (0). Total number of WBI patients was 234.
(23) Prof. Kumiko KARASAWA presented the summary of the WBI clinical data of breast cancer cases (234 patients / 235 breast lesions).
Overall 235 breast lesions in HF-WBI arm were enrolled in 56 months. Only 226 breast lesions data were analyzable in this workshop. All the patients except one completed protocol treatment. The median age was 49 years (range, 24-79). One hundred fourteen patients (50%) had right-sided breast cancer. The clinical stage 0 was in 38 patients (17%), IA in 116 (51%), IB in 3 (1%), IIA in 49 (22%), and IIB in 20 (9%), respectively. One hundred sixty-three patients received boost radiotherapy to tumor bed. The median treatment duration was 26 days (range, 18-54). Only 8 patients experienced treatment interruption. Acute dermatitis of grade 2 or higher was observed in 26 patients (11%). In regards with the late toxicity, grade 2 lung toxicity was observed in 1 patient, grade 2 skin toxicity in 1 patient, and grade 2 subcutaneous toxicity in 1 patient. One loco-regional recurrence, 3 distant metastases, and 2 breast cancer death were observed.
(24) An open discussion on the clinical data followed.
Some data are missing or probably wrongly filled out in registration sheet. All co-investigators need to re-check their data and send the corrected data. All co-investigators agreed on closing the registration.
Session 7: Future Plan and Drafting the Workshop Minutes
(25) Prof Shingo Kato proposed on-site 3D-IGBT training course at FNCA WS and it was agreed by all of the FNCA member states. One / Two Radiation Oncologist and one / two Medical Physicist expert and also the local host will be in-charge of the onsite training course.
(26) The next workshop is tentatively scheduled to be held in Bangladesh from November 11th 2018.
(27) The draft of the minutes was submitted by rapporteurs, discussed and amended. The draft of the minutes will be circulated after the workshop and finalized.
(28) Prof. Shingo KATO summarized and commented on all the sessions.
Session 8: Technical Visit at St. Frances Cabirini Medical Center
(29)The participants conducted a Technical Visit to St. Frances Cabrini Medical Center (Batangas).
Session 9: Technical Visit at St. Luke’s Medical Center
(30) The participants also visited St. Luke’s Medical Center (Global City).
Session 10: Open Lecture
(31) The Open Lecture was held in conjunction with the Postgraduate Course of the Department of Radiotherapy of JRRMMC. The theme was Global Issues in Radiation Oncology and was held at the Lung Center of the Philippines.
(32) Dr. Elisa B. Valdez,Chief of the medical professional staff, JRRMMC welcomed the audience with her remarks and Dr. Miriam Joy Calaguas gave her opening remarks.
(33) Mr. Tomoaki WADA gave a lecture about the FNCA. He introduced its overview and spoke about the on-going 8 projects' activities and achievements.
(34) Dr. Dang Huy Quoc Thinh, Vice Director- Head of Radiation Oncology, Ho Chi Minh City Oncology Hospital introduced the transition and results of NPC protocols in his hospital.
(35) Prof. Kumiko KARASAWA gave a lecture entitled "Breast Cancer: Are you ready to do Hypo Fractionation?".
(36) Prof. Tatsuya OHNO, Professor / Medical Director, Heavy Ion Medical Center, Gunma University spoke on Role of IGBT in Cervical Cancer.
(37) A Panel Discussion on IGBT followed. Dr. Rey H. de los Reyes and Prof. Shingo KATO moderated the session. The panelist were Prof. Masaru WAKATSUKI (Japan) and Dr. Kullathorn Thephamongkhol (Thailand). They discussed a case of cervical cancer.
(38) The last lecture was delivered by Prof. Takashi NAKANO, Professor,
Gunma University Graduate School of Medicine. He gave a lecture on Overview: Advanced Technologies in Radiation Oncology in Asia Today.
(39) Prof. Shingo KATO concluded the morning session of Open Lecture with his closing remarks.
(40) The workshop was officially closed.