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局部晚期子宫内膜癌的辅助化疗联合放疗
Adjuvant Chemotherapy plus Radiation for Locally Advanced Endometrial Cancer


Daniela Matei ... 肿瘤 妇产科和儿科 • 2019.06.13
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摘要


背景

Ⅲ期或ⅣA期子宫内膜癌有显著的全身和局部区域复发风险。

 

方法

在这项随机、3期试验中,我们在Ⅲ期或ⅣA期子宫内膜癌患者中研究了与单独采用6个周期的联合化疗相比,采用6个月的铂类化疗联合放疗(放化疗)是否与较长的无复发生存期(主要终点)相关。次要终点包括总生存期、急性和慢性毒性作用以及生活质量。

 

结果

在本试验纳入的813例患者中,有736例符合条件并被纳入无复发生存期分析;其中707例接受了随机分配的治疗(346例接受了放化疗,361例接受了单独化疗)。中位随访时间为47个月。60个月时,在放化疗组和单独化疗组中,无复发生存率的Kaplan-Meier估计值分别为59%(95%置信区间[CI],53%~65%)和58%(95% CI,53%~64%)(风险比,0.90;90% CI,0.74~1.10)。与单独化疗相比,放化疗与较低的5年阴道复发率(2% vs. 7%;风险比,0.36;95% CI,0.16~0.82)以及盆腔和主动脉旁淋巴结复发率(11% vs. 20%;风险比,0.43;95% CI,0.28~0.66)相关,但与较高的远处复发率相关(27% vs. 21%;风险比,1.36;95% CI,1.00~1.86)。放化疗组202例患者(58%)和单独化疗组227例患者(63%)报告了3级、4级或5级不良事件。

 

结论

Ⅲ期或ⅣA期子宫内膜癌患者采用化疗联合放疗的无复发生存期未超过单独采用化疗(由美国国立癌症研究所资助;在ClinicalTrials.gov注册号为NCT00942357)。





作者信息

Daniela Matei, M.D., Virginia Filiaci, Ph.D., Marcus E. Randall, M.D., David Mutch, M.D., Margaret M. Steinhoff, M.D., Paul A. DiSilvestro, M.D., Katherine M. Moxley, M.D., Yong M. Kim, M.D., Ph.D., Matthew A. Powell, M.D., David M. O’Malley, M.D., Nick M. Spirtos, M.D., William Small, Jr., M.D., Krishnansu S. Tewari, M.D., William E. Richards, M.D., John Nakayama, M.D., Ursula A. Matulonis, M.D., Helen Q. Huang, M.S., and David S. Miller, M.D.
From Northwestern University (D. Matei) and Loyola University (W.S.) — both in Chicago; NRG Oncology Statistical and Data Center, Roswell Park Comprehensive Cancer Center, Buffalo, NY (V.F., H.Q.H.); University of Kentucky, Lexington (M.E.R.); Washington University School of Medicine, Siteman Cancer Center, St. Louis (D. Mutch, M.A.P.); Women and Infants Hospital in Rhode Island–The Warren Alpert Medical School of Brown University, Providence (M.M.S., P.A.D.); Stephenson Cancer Center Gynecologic Cancers Clinic, University of Oklahoma Health Sciences Center, Oklahoma City (K.M.M.); Asan Medical Center, University of Ulsan, Songpa-gu, Seoul, South Korea (Y.M.K.); Ohio State University, Columbus (D.M.O.); Women’s Cancer Center of Nevada, Las Vegas (N.M.S.); University of California Irvine Medical Center, Irvine (K.S.T.); Lewis Cancer and Research Pavilion at St. Joseph’s–Candler, Savannah, GA (W.E.R.); Case Western Reserve University Hospital, Cleveland (J.N.); Dana–Farber Cancer Institute, Boston (U.A.M.); and the University of Texas Southwestern Medical Center, Dallas (D.S.M.). Address reprint requests to Dr. Matei at the Division of Gynecologic Oncology, Northwestern University, 303 E. Superior St., Lurie 4-107, Chicago, IL 60610, or at daniela.matei@northwestern.edu.

 

参考文献

1. Mariani A, Webb MJ, Keeney GL, Aletti G, Podratz KC. Assessment of prognostic factors in stage IIIA endometrial cancer. Gynecol Oncol 2002;86:38-44.

2. Mariani A, Webb MJ, Keeney GL, Haddock MG, Aletti G, Podratz KC. Stage IIIC endometrioid corpus cancer includes distinct subgroups. Gynecol Oncol 2002;87:112-117.

3. McMeekin DS, Lashbrook D, Gold M, Johnson G, Walker JL, Mannel R. Analysis of FIGO stage IIIc endometrial cancer patients. Gynecol Oncol 2001;81:273-278.

4. McMeekin DS, Lashbrook D, Gold M, et al. Nodal distribution and its significance in FIGO stage IIIc endometrial cancer. Gynecol Oncol 2001;82:375-379.

5. Bruzzone M, Miglietta L, Franzone P, Gadducci A, Boccardo F. Combined treatment with chemotherapy and radiotherapy in high-risk FIGO stage III-IV endometrial cancer patients. Gynecol Oncol 2004;93:345-352.

6. Mundt AJ, Murphy KT, Rotmensch J, Waggoner SE, Yamada SD, Connell PP. Surgery and postoperative radiation therapy in FIGO Stage IIIC endometrial carcinoma. Int J Radiat Oncol Biol Phys 2001;50:1154-1160.

7. Nelson G, Randall M, Sutton G, Moore D, Hurteau J, Look K. FIGO stage IIIC endometrial carcinoma with metastases confined to pelvic lymph nodes: analysis of treatment outcomes, prognostic variables, and failure patterns following adjuvant radiation therapy. Gynecol Oncol 1999;75:211-214.

8. Schorge JO, Molpus KL, Goodman A, Nikrui N, Fuller AF Jr. The effect of postsurgical therapy on stage III endometrial carcinoma. Gynecol Oncol 1996;63:34-39.

9. Randall ME, Filiaci VL, Muss H, et al. Randomized phase III trial of whole-abdominal irradiation versus doxorubicin and cisplatin chemotherapy in advanced endometrial carcinoma: a Gynecologic Oncology Group study. J Clin Oncol 2006;24:36-44.

10. Greven K, Winter K, Underhill K, Fontenesci J, Cooper J, Burke T. Final analysis of RTOG 9708: adjuvant postoperative irradiation combined with cisplatin/paclitaxel chemotherapy following surgery for patients with high-risk endometrial cancer. Gynecol Oncol 2006;103:155-159.

11. Homesley HD, Filiaci V, Gibbons SK, et al. A randomized phase III trial in advanced endometrial carcinoma of surgery and volume directed radiation followed by cisplatin and doxorubicin with or without paclitaxel: a Gynecologic Oncology Group study. Gynecol Oncol 2009;112:543-552.

12. Miller D, Filiaci V, Fleming G, et al. Randomized phase III noninferiority trial of first-line chemotherapy for metastatic or recurrent endometrial carcinoma: a Gynecologic Oncology Group study. Gynecol Oncol 2012;125:771-771. abstract.

13. Fleming GF, Brunetto VL, Cella D, et al. Phase III trial of doxorubicin plus cisplatin with or without paclitaxel plus filgrastim in advanced endometrial carcinoma: a Gynecologic Oncology Group study. J Clin Oncol 2004;22:2159-2166.

14. Yost KJ, Eton DT. Combining distribution- and anchor-based approaches to determine minimally important differences: the FACIT experience. Eval Health Prof 2005;28:172-191.

15. Aalders J, Abeler V, Kolstad P, Onsrud M. Postoperative external irradiation and prognostic parameters in stage I endometrial carcinoma: clinical and histopathologic study of 540 patients. Obstet Gynecol 1980;56:419-427.

16. Blake P, Swart AM, Orton J, et al. Adjuvant external beam radiotherapy in the treatment of endometrial cancer (MRC ASTEC and NCIC CTG EN.5 randomised trials): pooled trial results, systematic review, and meta-analysis. Lancet 2009;373:137-146.

17. Creutzberg CL, van Putten WL, Koper PC, et al. Surgery and postoperative radiotherapy versus surgery alone for patients with stage-1 endometrial carcinoma: multicentre randomised trial. Lancet 2000;355:1404-1411.

18. Nout RA, Smit VT, Putter H, et al. Vaginal brachytherapy versus pelvic external beam radiotherapy for patients with endometrial cancer of high-intermediate risk (PORTEC-2): an open-label, non-inferiority, randomised trial. Lancet 2010;375:816-823.

19. Keys HMRJ, Roberts JA, Brunetto VL, et al. A phase III trial of surgery with or without adjunctive external pelvic radiation therapy in intermediate risk endometrial adenocarcinoma: a Gynecologic Oncology Group study. Gynecol Oncol 2004;92:744-751.

20. Meyer LA, Bohlke K, Powell MA, et al. Postoperative radiation therapy for endometrial cancer: American Society of Clinical Oncology clinical practice guideline endorsement of the American Society for Radiation Oncology evidence-based guideline. J Clin Oncol 2015;33:2908-2913.

21. Mundt AJ, McBride R, Rotmensch J, Waggoner SE, Yamada SD, Connell PP. Significant pelvic recurrence in high-risk pathologic stage I–IV endometrial carcinoma patients after adjuvant chemotherapy alone: implications for adjuvant radiation therapy. Int J Radiat Oncol Biol Phys 2001;50:1145-1153.

22. Stewart KD, Martinez AA, Weiner S, et al. Ten-year outcome including patterns of failure and toxicity for adjuvant whole abdominopelvic irradiation in high-risk and poor histologic feature patients with endometrial carcinoma. Int J Radiat Oncol Biol Phys 2002;54:527-535.

23. Lewin SN. Revised FIGO staging system for endometrial cancer. Clin Obstet Gynecol 2011;54:215-218.

24. Havrilesky LJ, Cragun JM, Calingaert B, et al. The prognostic significance of positive peritoneal cytology and adnexal/serosal metastasis in stage IIIA endometrial cancer. Gynecol Oncol 2007;104:401-405.

25. Takeshima N, Nishida H, Tabata T, Hirai Y, Hasumi K. Positive peritoneal cytology in endometrial cancer: enhancement of other prognostic indicators. Gynecol Oncol 2001;82:470-473.

26. Sood BM, Jones J, Gupta S, et al. Patterns of failure after the multimodality treatment of uterine papillary serous carcinoma. Int J Radiat Oncol Biol Phys 2003;57:208-216.

27. Alektiar KM, Makker V, Abu-Rustum NR, et al. Concurrent carboplatin/paclitaxel and intravaginal radiation in surgical stage I-II serous endometrial cancer. Gynecol Oncol 2009;112:142-145.

28. Alektiar KM, McKee A, Lin O, et al. Is there a difference in outcome between stage I-II endometrial cancer of papillary serous/clear cell and endometrioid FIGO grade 3 cancer? Int J Radiat Oncol Biol Phys 2002;54:79-85.

29. Foerster R, Kluck R, Rief H, Rieken S, Debus J, Lindel K. Survival of women with clear cell and papillary serous endometrial cancer after adjuvant radiotherapy. Radiat Oncol 2014;9:141-141.

30. Kiess AP, Damast S, Makker V, et al. Five-year outcomes of adjuvant carboplatin/paclitaxel chemotherapy and intravaginal radiation for stage I-II papillary serous endometrial cancer. Gynecol Oncol 2012;127:321-325.

31. Maggi R, Lissoni A, Spina F, et al. Adjuvant chemotherapy vs radiotherapy in high-risk endometrial carcinoma: results of a randomised trial. Br J Cancer 2006;95:266-271.

32. Susumu N, Sagae S, Udagawa Y, et al. Randomized phase III trial of pelvic radiotherapy versus cisplatin-based combined chemotherapy in patients with intermediate- and high-risk endometrial cancer: a Japanese Gynecologic Oncology Group study. Gynecol Oncol 2008;108:226-233.

33. Hogberg T, Signorelli M, de Oliveira CF, et al. Sequential adjuvant chemotherapy and radiotherapy in endometrial cancer — results from two randomised studies. Eur J Cancer 2010;46:2422-2431.

34. de Boer SM, Powell ME, Mileshkin L, et al. Adjuvant chemoradiotherapy versus radiotherapy alone for women with high-risk endometrial cancer (PORTEC-3): final results of an international, open-label, multicentre, randomised, phase 3 trial. Lancet Oncol 2018;19:295-309.

35. Thigpen JT, Brady MF, Homesley HD, et al. Phase III trial of doxorubicin with or without cisplatin in advanced endometrial carcinoma: a Gynecologic Oncology Group study. J Clin Oncol 2004;22:3902-3908.

36. Geller MA, Ivy JJ, Ghebre R, et al. A phase II trial of carboplatin and docetaxel followed by radiotherapy given in a “Sandwich” method for stage III, IV, and recurrent endometrial cancer. Gynecol Oncol 2011;121:112-117.

37. Lu SM, Chang-Halpenny C, Hwang-Graziano J. Sequential versus “sandwich” sequencing of adjuvant chemoradiation for the treatment of stage III uterine endometrioid adenocarcinoma. Gynecol Oncol 2015;137:28-33.

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