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A Randomized Controlled Trial Comparing Concurrent J Gynecol Oncol. 2019 Jul;30(4):e82 https://doi.org/10.3802/jgo.2019.30.e82 pISSN 2005-0380·eISSN 2005-0399 Original Article A randomized controlled trial comparing concurrent chemoradiation versus concurrent chemoradiation followed by adjuvant chemotherapy in locally advanced cervical cancer patients: ACTLACC trial Siriwan Tangjitgamol ,1 Ekkasit Tharavichitkul ,2 Chokaew Tovanabutra ,3 Kanisa Rongsriyam ,4 Tussawan Asakij ,5 Kannika Paengchit ,6 Jirasak Sukhaboon ,7 Somkit Penpattanagul ,8 Apiradee Kridakara ,9 Received: Oct 28, 2018 Jitti Hanprasertpong ,10 Kittisak Chomprasert ,3 Sirentra Wanglikitkoon ,8 Revised: Mar 18, 2019 10 11 4 Accepted: Mar 18, 2019 Thiti Atjimakul , Piyawan Pariyawateekul , Kanyarat Katanyoo , Prapai Tanprasert ,12 Wanwipa Janweerachai,13 Duangjai Sangthawan ,14 Correspondence to Jakkapan Khunnarong ,1 Taywin Chottetanaprasith ,15 Siriwan Tangjitgamol Busaba Supawattanabodee ,16 Prasert Lertsanguansinchai ,17 Department of Obstetrics and Gynecology, Jatupol Srisomboon ,18 Wanrudee Isaranuwatchai ,19,20 Vichan Lorvidhaya 3 Faculty of Medicine Vajira Hospital, Navamindradhiraj University, 681 Samsen 1Department of Obstetrics and Gynecology, Faculty of Medicine Vajira Hospital, Navamindradhiraj University, Road, Khet Dusit, Bangkok 10300, Thailand. Bangkok, Thailand E-mail: [email protected] 2Department of Radiology, Faculty of Medicine, Chiang Mai University, Chiang Mai, Thailand [email protected] 3Radiation Oncology Section, Chonburi Cancer Hospital, Chonburi, Thailand 4Department of Radiology, Faculty of Medicine Vajira Hospital, Navamindradhiraj University, Bangkok, Thailand Copyright © 2019. Asian Society of 5Radiation Oncology Section, Lampang Cancer Hospital, Lampang, Thailand Gynecologic Oncology, Korean Society of 6Gynecologic Oncology section, Lampang Cancer Hospital, Lampang, Thailand Gynecologic Oncology 7Radiation Oncology Section, Lopburi Cancer Hospital, Lopburi, Thailand This is an Open Access article distributed 8Radiation Oncology Section, Udonthani Cancer Hospital, Udon Thani, Thailand under the terms of the Creative Commons 9Radiation Oncology Section, Bhumibol Adulyadej Hospital, Bangkok, Thailand Attribution Non-Commercial License (https:// 10Department of Obstetrics and Gynecology, Prince of Songkla University, Songkhla, Thailand 11 creativecommons.org/licenses/by-nc/4.0/) Obstetrics and Gynecology Section, Bhumibol Adulyadej Hospital, Bangkok, Thailand 12 which permits unrestricted non-commercial Obstetrics and Gynecology Section, Rajburi Hospital, Ratchaburi, Thailand 13 use, distribution, and reproduction in any Radiation Oncology Section, Rajburi Hospital, Ratchaburi, Thailand 14Department of Radiology, Prince of Songkla University, Songkhla, Thailand medium, provided the original work is properly 15Radiation Oncology Section, Ubonratchathani Cancer Hospital, Ubon Ratchathani, Thailand cited. 16Department of Basic Sciences, Faculty of Medicine Vajira Hospital, Navamindradhiraj University, Bangkok, Thailand ORCID iDs 17Department of Radiology, King Chulalongkorn Memorial Hospital, Bangkok, Thailand Siriwan Tangjitgamol 18Department of Obstetrics and Gynecology, Faculty of Medicine, Chiang Mai University, Chiang Mai, Thailand https://orcid.org/0000-0001-5367-8884 19Health Intervention and Technology Assessment Program, Nonthaburi, Thailand Ekkasit Tharavichitkul 20St. Michael's Hospital, University of Toronto, Toronto, Canada https://orcid.org/0000-0002-5495-1421 Chokaew Tovanabutra https://orcid.org/0000-0003-2589-8470 Kanisa Rongsriyam ABSTRACT https://orcid.org/0000-0002-9785-1201 Tussawan Asakij Objective: To compare response rate and survivals of locally advanced stage cervical cancer https://orcid.org/0000-0003-3906-9980 patients who had standard concurrent chemoradiation therapy (CCRT) alone to those who Kannika Paengchit https://orcid.org/0000-0002-2369-6106 had adjuvant chemotherapy (ACT) after CCRT. Jirasak Sukhaboon Methods: Patients aged 18–70 years who had International Federation of Gynecology and https://orcid.org/0000-0002-4892-0645 Obstetrics stage IIB–IVA without para-aortic lymph node enlargement, Eastern Cooperative https://ejgo.org 1/13 Adjuvant chemotherapy for cervical cancer Somkit Penpattanagul Oncology Group scores 0–2, and non-aggressive histopathology were randomized to have https://orcid.org/0000-0001-5860-9554 CCRT with weekly cisplatin followed by observation (arm A) or by ACT with paclitaxel plus Apiradee Kridakara carboplatin every 4 weeks for 3 cycles (arm B). https://orcid.org/0000-0003-3286-5052 Results: Jitti Hanprasertpong Data analysis of 259 patients showed no significant difference in complete responses https://orcid.org/0000-0002-0640-6824 at 4 months after treatment between arm A (n=129) and arm B (n=130): 94.1% vs. 87.0% Kittisak Chomprasert (p=0.154) respectively. With the median follow-up of 27.4 months, 15.5% of patients in arm A https://orcid.org/0000-0002-8163-1626 and 10.8% in arm B experienced recurrences (p=0.123). There were no significant differences Sirentra Wanglikitkoon of overall or loco-regional failure. However, systemic recurrences were significantly lower https://orcid.org/0000-0003-1798-8871 in arm B than arm A: 5.4% vs. 10.1% (p=0.029). The 3-year progression-free survival (PFS) Thiti Atjimakul https://orcid.org/0000-0003-3460-8236 and 3-year overall survival (OS) of the patients in both arms were not significantly different. Piyawan Pariyawateekul The hazard ratio of PFS and OS of arm B compared to arm A were 1.26 (95% CI=0.82–1.96; https://orcid.org/0000-0001-7705-6537 p=0.293) and 1.42 (95% CI=0.81–2.49; p=0.221) respectively. Kanyarat Katanyoo Conclusions: ACT with paclitaxel plus carboplatin after CCRT did not improve response rate https://orcid.org/0000-0002-6561-5589 and survival compared to CCRT alone. Only significant decrease of systemic recurrences with Prapai Tanprasert https://orcid.org/0000-0002-9237-7539 ACT was observed, but not overall or loco-regional failure. Duangjai Sangthawan https://orcid.org/0000-0003-4434-8917 Trial Registration: ClinicalTrials.gov Identifier: NCT02036164 Jakkapan Khunnarong Thai Clinical Trials Registry Identifier: TCTR 20140106001 https://orcid.org/0000-0002-6307-1346 Taywin Chottetanaprasith Keywords: Uterine Cervical Neoplasm; Concurrent; Chemoradiotherapy; https://orcid.org/0000-0003-1295-3514 Adjuvant Chemotherapy Busaba Supawattanabodee https://orcid.org/0000-0002-5282-1500 Prasert Lertsanguansinchai https://orcid.org/0000-0002-5819-9580 INTRODUCTION Jatupol Srisomboon https://orcid.org/0000-0003-3416-1710 Wanrudee Isaranuwatchai Cervical cancer is a major worldwide health problem of women especially in developing https://orcid.org/0000-0002-8368-6065 countries. In Thailand, it is the second most common female cancer after breast cancer Vichan Lorvidhaya and remains the leading cause of death among women. An average age standardized https://orcid.org/0000-0001-8203-0761 incidence rate was 29.2 per 100,000 women with a death rate of 15.2 per 100,000 women or approximately half of its incidence [1]. This is probably due to a suboptimal screening Trial Registration ClinicalTrials.gov Identifier: NCT02036164 coverage of the target population, leading to a high proportion of locally advanced and Thai Clinical Trials Registry Identifier:TCTR advanced stage diseases and poor overall prognosis [2]. 20140106001 Concurrent chemoradiation therapy (CCRT) has been used as a standard treatment for locally Funding This trial was granted by the Thailand National advanced cervical cancer (LACC) for over two decades. Despite a survival improvement with Research Fund. an addition of concurrent chemotherapy to radiation, high rates of local and distant failures (17% and 18%, respectively) were still encountered [3]. A search for other treatments to Conflict of Interest improve treatment outcomes in this particular group of cervical cancer patients is important. No potential conflict of interest relevant to this article was reported. Many treatment modifications which have been used with CCRT were adding novel Author Contributions targeted agents with chemotherapy, using other chemotherapeutic regimens either alone Conceptualization: T.S., L.V.; Data curation: or in combination with the standard platinum drug, modifying the dose or schedule of T.S., T.E., T.C., R.K., aA.T., P.K., S.J., P.S., K.A., H.J., C.K., W.S., bA.T., P.P., K.K., T.P., J.W., S.D., chemotherapy, or giving additional chemotherapy (adjuvant or consolidation chemotherapy) C.T., L.V.; Formal analysis: T.S., I.W.; Funding after CCRT. acquisition: T.S.; Investigation: T.S., L.V.; Project administration: T.S., T.E., T.C., A.T., P.K., The role of additional chemotherapy after CCRT for LACC has been explored in many S.J., P.S., K.A., H.J., K.K., S.B., L.P., S.J., L.V.; studies [4-7]. Although all prospective phase II studies showed an increased response rate Supervision: T.S., L.V.; Validation: T.S., R.K.; with adjuvant or consolidation chemotherapy with high 80%–90% survival rates [4-7], the 3 Writing - original draft: T.S.; Writing - review & randomized controlled trials of adjuvant chemotherapy (ACT) had inconsistent data [8-10]. https://ejgo.org https://doi.org/10.3802/jgo.2019.30.e82 2/13 Adjuvant chemotherapy for cervical cancer editing: T.S., T.E., T.C., R.K., aA.T., P.K., S.J., P.S., Two trials showed increased progression-free survival (PFS) or disease-free survival (DFS) K.A., H.J., C.K., W.S., bA.T., P.P., T.P., J.W., S.D., using ACT after CCRT 9[ ,10] whereas the other trial could not demonstrate
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