Concurrent Weekly Nedaplatin, External Beam Radiotherapy and High-Dose-Rate Brachytherapy in Patients with FIGO Stage IIIb Cervical Cancer: A Comparison with a Cohort Treated by Radiotherapy AloneMabuchi S.a · Ugaki H.a · Isohashi F.b · Yoshioka Y.b · Temma K.a · Yada-Hashimoto N.a · Takeda T.a · Yamamoto T.a · Yoshino K.a · Nakajima R.a · Kuragaki C.a · Morishige K.a · Enomoto T.a · Inoue T.b · Kimura T.a
Departments of aObstetrics and Gynecology, and bRadiation Oncology, Osaka University Graduate School of Medicine, Suita, Japan
Do you have an account?
- Rent for 48h to view
- Buy Cloud Access for unlimited viewing via different devices
- Synchronizing in the ReadCube Cloud
- Printing and saving restrictions apply
Rental: USD 8.50
Cloud: USD 20.00
Article / Publication Details
Objectives: The aim of this study was to evaluate whether nedaplatin-based concurrent chemoradiotherapy (CCRT) using high-dose-rate intracavitary brachytherapy (HDR-ICBT) is superior to radiotherapy (RT) alone in patients with FIGO stage IIIb cervical cancer. Methods: The records of 41 consecutive women treated either with nedaplatin-based CCRT using HDR-ICBT (n = 20) or RT alone (nonrandomized control group, n = 21) for stage IIIb cervical cancer were retrospectively reviewed. The activity and toxicity were compared between the two treatment groups. Progression-free survival (PFS) and overall survival (OS) were the main endpoints. Results: The 5-year overall survival rates in the CCRT and RT groups were 65 and 33.3%, respectively. The median OS of the CCRT and RT groups were 60 and 29 months, respectively. CCRT was significantly superior to RT alone with regard to PFS (p = 0.0015) and OS (p = 0.0364). The frequency of acute grade 3–4 toxicity was significantly higher in the CCRT group than in the RT group. However, no statistically significant difference was observed with regard to severe late toxicity. Conclusions: Nedaplatin-based concurrent chemoradiotherapy was safely performed and significantly improved the prognosis of patients with FIGO stage IIIb cervical cancer. This treatment can be considered as an alternative to cisplatin-based chemoradiotherapy in this patient population.
© 2010 S. Karger AG, Basel
- Benedet JL, Odicino F, Maisonneuve P, Beller U, Creasman WT, Heintz AP, Ngan HY, Pecorelli S: Carcinoma of the cervix uteri. Int J Gynaecol Obstet 2003;83(suppl 1):41–78.
Stehman FB, Perez CA, Kurman RJ, et al: Uterine cervix; in Hoskins WJ, Perez CA, Young RC (eds): Principles and Practice of Gynecology Oncology. Philadelphia, Lippincott Williams & Wilkins, 2000, pp 841–918.
- Kovalic JJ, Perez CA, Grigsby PW, Lockett MA: The effect of volume of disease in patients with carcinoma of the uterine cervix. Int J Radiat Oncol Biol Phys 1991;21:905–910.
Whitney CW, Sause W, Bundy BN, Malfetano JH, Hannigan EV, Fowler WC Jr, Clarke-Pearson DL, Liao SY: Randomized comparison of fluorouracil plus cisplatin versus hydroxyurea as an adjunct to radiation therapy in stage IIB–IVA carcinoma of the cervix with negative para-aortic lymph nodes: a Gynecologic Oncology Group and Southwest Oncology Group study. J Clin Oncol 1999;17:1334–1335.
- Morris M, Eifel PJ, Lu J, Grigsby PW, Levenback C, Stevens RE, Rotman M, Gershenson DM, Mutch DG: Pelvic radiation with concurrent chemotherapy compared with pelvic and para-aortic radiation for high-risk cervical cancer. N Engl J Med 1999;340:1137–1143.
- Rose PG, Bundy BN, Watkins EB, Thigpen JT, Deppe G, Maiman MA, Clarke-Pearson DL, Insalaco S: Concurrent cisplatin-based radiotherapy and chemotherapy for locally advanced cervical cancer. N Engl J Med 1999;340:1144–1153.
- Keys HM, Bundy BN, Stehman FB, Muderspach LI, Chafe WE, Suggs CL 3rd, Walker JL, Gersell D: Cisplatin, radiation, and adjuvant hysterectomy compared with radiation and adjuvant hysterectomy for bulky stage IB cervical carcinoma. N Engl J Med 1999;340:1154–1161.
- Eifel PJ, Winter K, Morris M, Levenback C, Grigsby PW, Cooper J, Rotman M, Gershenson D, Mutch DG: Pelvic irradiation with concurrent chemotherapy versus pelvic and para-aortic irradiation for high-risk cervical cancer: an update of Radiation Therapy Oncology Group trial (RTOG) 90-01. J Clin Oncol 2004;22:872–880.
- Lee SK, Jones HW 3rd: Prognostic significance of ureteral obstruction in primary cervical cancer. Int J Gynaecol Obstet 1994;44:59–65.
- Monk BJ, Alberts DS, Burger RA, Fanta PT, Hallum AV 3rd, Hatch KD, Salmon SE: In vitro phase II comparison of the cytotoxicity of a novel platinum analog, nedaplatin (254-S), with that of cisplatin and carboplatin against fresh, human cervical cancers. Gynecol Oncol 1998;71:308–312.
- Sasaki Y, Shinkai T, Eguchi K, Tamura T, Ohe Y, Ohmori T, Saijo N: Prediction of the antitumor activity of new platinum analogs based on their ex vivo pharmacodynamics as determined by bioassay. Cancer Chemother Pharmacol 1991;27:263–270.
- Uehara T, Watanabe H, Itoh F, Inoue S, Koshida H, Nakamura M, Yamate J, Maruyama T: Nephrotoxicity of a novel antineoplastic platinum complex, nedaplatin: a comparative study with cisplatin in rats. Arch Toxicol 2005;79:451–460.
- Kawai Y, Taniuchi S, Okahara S, Nakamura M, Gemba M: Relationship between cisplatin or nedaplatin-induced nephrotoxicity and renal accumulation. Biol Pharm Bull 2005;28:1385–1388.
- Fukuda M, Shinkai T, Eguchi K, Sasaki Y, Tamura T, Ohe Y, Kojima A, Oshita F, Hara K, Saijo N: Phase II study of (glycolate-O,O′)diammineplatinum(II), a novel platinum complex, in the treatment of non-small-cell lung cancer. Cancer Chemother Pharmacol 1990;26:393–396.
- Inuyama Y, Miyake H, Horiuchi M, Hayasaki K, Komiyama S, Ota K: An early phase II clinical study of cis-diammine glycolatoplatinum, 254-S, for head and neck cancers. Gan To Kagaku Ryoho 1992;19:863–869.
- Kato T, Nishimura H, Yakushiji M, Noda K, Terashima Y, Takeuchi S, Takamizawa H, Suzuki M, Arai M, Ota M, et al: Phase II study of 254-S (cis-diammine glycolatoplatinum) for gynecological cancer. Gan To Kagaku Ryoho 1992;19:695–701.
- Mabuchi S, Morishige K, Fujita M, Tsutsui T, Sakata M, Enomoto T, Kimura T: The activity of carboplatin and paclitaxel for recurrent cervical cancer after definitive radiotherapy. Gynecl Oncol 2009;113:200–204.
- Nakamura Y, Hasegawa M, Hayakawa K, Matsuura M, Suzuki Y, Nasu S, Yamakawa M, Mitsuhashi N, Niibe H: Induction of p53-dependent apoptosis in vivo by nedaplatin and ionizing radiation. Oncol Rep 2000;7:261–265.
- Tanaka T, Yukawa K, Umesaki N: Radiation reduces carboplatin sensitivity and enhances nedaplatin sensitivity in cervical squamous cell carcinoma in vitro. Eur J Gynaecol Oncol 2007;28:352–355.
- Sato Y, Takayama T, Sagawa T, Okamoto T, Miyanishi K, Sato T, Araki H, Iyama S, Abe S, Murase K, Takimoto R, Nagakura H, Hareyama M, Kato J, Niitsu Y: A phase I/II study of nedaplatin and 5-fluorouracil with concurrent radiotherapy in patients with esophageal cancer. Cancer Chemother Pharmacol 2006;58:570–576.
- Yoshinaga K, Niikura H, Ogawa Y, Nemoto K, Nagase S, Takano T, Ito K, Yaegashi N: Phase I trial of concurrent chemoradiation with weekly nedaplatin in patients with squamous cell carcinoma of the uterine cervix. Gynecol Oncol 2007;104:36–40.
- Yokoyama Y, Takano T, Nakahara K, Shoji T, Sato H, Yamada H, Yaegashi N, Okamura K, Kurachi H, Sugiyama T, Tanaka T, Sato A, Tase T, Mizunuma H: A phase II multicenter trial of concurrent chemoradiotherapy with weekly nedaplatin in advanced uterine cervical carcinoma: Tohoku Gynecologic Cancer Unit Study. Oncol Rep 2008;19:1551–1556.
- Kameyama Y, Okazaki N, Nakagawa M, Koshida H, Nakamura M, Gemba M: Nephrotoxicity of a new platinum compound, 254-S, evaluated with rat kidney cortical slices. Toxicol Lett 1990;52:15–24.
- Sasaki Y, Amano T, Morita M, Shinkai T, Eguchi K, Tamura T, Ohe Y, Kojima A, Saijo N: Phase I study and pharmacological analysis of cis-diammine(glycolato)platinum (254-S; NSC 375101D) administered by 5-day continuous intravenous infusion. Cancer Res 1991;51:1472–1477.
- Toita T, Kodaira T, Shinoda A, Uno T, Akino Y, Mitsumori M, Teshima T: Patterns of radiotherapy practice for patients with cervical cancer (1999–2001): patterns of care study in Japan. Int J Radiat Oncol Biol Phys 2008;70:788–794.
- Teshima T, Inoue T, Ikeda H, Miyata Y, Nishiyama K, Inoue T, Murayama S, Yamasaki H, Kozuka T: High-dose rate and low-dose rate intracavitary therapy for carcinoma of the uterine cervix: final results of Osaka University Hospital. Cancer 1993;72:2409–2414.
- Hareyama M, Sakata K, Oouchi A, Nagakura H, Shido M, Someya M, Koito K: High-dose-rate versus low-dose-rate intracavitary therapy for carcinoma of the uterine cervix: a randomized trial. Cancer 2002;94:117–124.
- Lertsanguansinchai P, Lertbutsayanukul C, Shotelersuk K, Khorprasert C, Rojpornpradit P, Chottetanaprasith T, Srisuthep A, Suriyapee S, Jumpangern C, Tresukosol D, Charoonsantikul C: Phase III randomized trial comparing LDR and HDR brachytherapy in treatment of cervical carcinoma. Int J Radiat Oncol Biol Phys 2004;59:1424–1431.
- Cox JD, Stetz J, Pajak TF: Toxicity criteria of the Radiation Therapy Oncology Group (RTOG) and the European Organization for Research and Treatment of Cancer (EORTC). Int J Radiat Oncol Biol Phys 1995;31:1341–1346.
- Pearcey R, Brundage M, Drouin P, Jeffrey J, Johnston D, Lukka H, MacLean G, Souhami L, Stuart G, Tu D: Phase III trial comparing radical radiotherapy with and without cisplatin chemotherapy in patients with advanced squamous cell cancer of the cervix. J Clin Oncol 2002;20:891–893.
- Niibe Y, Tsunoda S, Jobo T, Imai M, Matsuo K, Matsunaga K, Unno N, Hayakawa K: Phase II study of radiation therapy combined with weekly nedaplatin in locally advanced uterine cervical carcinoma (LAUCC): Kitasato Gynecologic Radiation Oncology Group (KGROG 0501) – initial analysis. Eur J Gynaecol Oncol 2008;29:222–224.
- Kodama J, Takemoto M, Seki N, Nakamura K, Hongo A, Kanazawa S, Hiramatsu Y: Phase I study of weekly nedaplatin and concurrent pelvic radiotherapy as adjuvant therapy after radical surgery for cervical cancer. Int J Gynecol Cancer 2008;18:1037–1041.
- Toita T, Moromizato H, Ogawa K, Kakinohana Y, Maehama T, Kanazawa K, Murayama S: Concurrent chemoradiotherapy using high-dose-rate intracavitary brachytherapy for uterine cervical cancer. Gynecol Oncol 2005;96:665–670.
- Chung YL, Jian JJ, Cheng SH, Hsieh CI, Tan TD, Chang HJ, Hung CF, Horng CF, Soong T, Tsou MH: Extended-field radiotherapy and high-dose-rate brachytherapy with concurrent and adjuvant cisplatin-based chemotherapy for locally advanced cervical cancer: a phase I/II study. Gynecol Oncol 2005;97:126–135.
- Chen SW, Liang JA, Hung YC, Yeh LS, Chang WC, Lin WC, Yang SN, Lin FJ: Concurrent weekly cisplatin plus external beam radiotherapy and high-dose rate brachytherapy for advanced cervical cancer: a control cohort comparison with radiation alone on treatment outcome and complications. Int J Radiat Oncol Biol Phys 2006;66:1370–1377.
- Pötter R, Dimopoulos J, Bachtiary B, Sissolak G, Klos B, Rheinthaller A, Kirisits C, Knocke-Abulesz TH: 3D conformal HDR-brachy- and external beam therapy plus simultaneous cisplatin for high-risk cervical cancer: clinical experience with 3 year follow-up. Radiother Oncol 2006;79:80–86.
- Novetsky AP, Einstein MH, Goldberg GL, Hailpern SM, Landau E, Fields AL, Mutyala S, Kalnicki S, Garg M: Efficacy and toxicity of concomitant cisplatin with external beam pelvic radiotherapy and two high-dose-rate brachytherapy insertions for the treatment of locally advanced cervical cancer. Gynecol Oncol 2007;105:635–640.
- Green JA, Kirwan JM, Tierney JF, Symonds P, Fresco L, Collingwood M, Williams CJ: Survival and recurrence after concomitant chemotherapy and radiotherapy for cancer of the uterine cervix: a systematic review and meta-analysis. Lancet 2001;358:781–786.
Article / Publication Details
Copyright / Drug Dosage / DisclaimerCopyright: All rights reserved. No part of this publication may be translated into other languages, reproduced or utilized in any form or by any means, electronic or mechanical, including photocopying, recording, microcopying, or by any information storage and retrieval system, without permission in writing from the publisher.
Drug Dosage: The authors and the publisher have exerted every effort to ensure that drug selection and dosage set forth in this text are in accord with current recommendations and practice at the time of publication. However, in view of ongoing research, changes in government regulations, and the constant flow of information relating to drug therapy and drug reactions, the reader is urged to check the package insert for each drug for any changes in indications and dosage and for added warnings and precautions. This is particularly important when the recommended agent is a new and/or infrequently employed drug.
Disclaimer: The statements, opinions and data contained in this publication are solely those of the individual authors and contributors and not of the publishers and the editor(s). The appearance of advertisements or/and product references in the publication is not a warranty, endorsement, or approval of the products or services advertised or of their effectiveness, quality or safety. The publisher and the editor(s) disclaim responsibility for any injury to persons or property resulting from any ideas, methods, instructions or products referred to in the content or advertisements.