Progression-free survival at 2 years is a reliable surrogate marker for the 5-year survival rate in patients with locally advanced non-small cell lung cancer treated with chemoradiotherapy

BMC Cancer

Hiroaki Akamatsu⁴  Keita Mori³  Tateaki Naito⁴  Hisao Imai⁴  Akira Ono⁴  Takehito Shukuya²  Tetsuhiko Taira⁴  Hirotsugu Kenmotsu⁴  Haruyasu Murakami⁴  Masahiro Endo⁵  Hideyuki Harada¹  Toshiaki Takahashi⁴  Nobuyuki Yamamoto⁶ 

[1] Division of Radiation Oncology, Shizuoka Cancer Center, Shimonagakubo, Nagaizumi-cho Sunto-gun, Shizuoka, Japan

[2] Department of Respiratory Medicine, Juntendo University, Hongou Bunkyou-ku, Tokyo, Japan

[3] Clinical Trial Management Department, Shizuoka Cancer Center, Shimonagakubo, Nagaizumi-cho Sunto-gun, Shizuoka, Japan

[4] Division of Thoracic Oncology, Shizuoka Cancer Center, Shimonagakubo, 1007 Shimonagakubo, Nagaizumi-cho Sunto-gun, Shizuoka 411-8777, Japan

[5] Division of Diagnostic Radiology, Shizuoka Cancer Center, Shimonagakubo, Nagaizumi-cho Sunto-gun, Shizuoka, Japan

[6] Third Department of Internal Medicine, Wakayama Medical University, Kimiidera, Wakayama, Japan

关键词: Progression-free survival;    Overall response rate;    Surrogate endpoint;    Chemoradiotherapy;    Locally advanced non-small cell lung cancer;   

Others  :  859150
DOI  :  10.1186/1471-2407-14-18

 received in 2013-09-02, accepted in 2014-01-09,  发布年份 2014

【 摘 要 】

Background

In locally advanced Non-Small-Cell Lung Cancer (LA-NSCLC) patients treated with chemoradiotherapy (CRT), optimal surrogate endpoint for cure has not been fully investigated.

Methods

The clinical records of LA-NSCLC patients treated with concurrent CRT at Shizuoka Cancer Center between Sep. 2002 and Dec. 2009 were reviewed. The primary outcome of this study was to evaluate the surrogacy of overall response rate (ORR) and progression-free survival (PFS) rate at 3-month intervals (from 9 to 30 months after the initiation of treatment) for the 5-year survival rate. Landmark analyses were performed to assess the association of these outcomes with the 5-year survival rate.

Results

One hundred and fifty-nine patients were eligible for this study. The median follow-up time for censored patients was 57 months. The ORR was 72%, median PFS was 12 months, and median survival time was 39 months.

Kaplan-Meier curve of progression-free survival and hazard ratio of landmark analysis at each time point suggest that most progression occurred within 2 years. With regard to 5-year survival rate, patients with complete response, or partial response had a rate of 45%. Five-year survival rates of patients who were progression free at each time point (3-months intervals from 9 to 30 months) were 53%, 69%, 75%, 82%, 84%, 89%, 90%, and 90%, respectively. The rate gradually increased in accordance with progression-free interval extended, and finally reached a plateau at 24 months.

Conclusions

Progression-free survival at 2 years could be a reliable surrogate marker for the 5-year survival rate in LA-NSCLC patients treated with concurrent CRT.

【 授权许可】

   
2014 Akamatsu et al.; licensee BioMed Central Ltd.

【 图 表 】

【 参考文献 】

• [1]Jemal A, Bray F, Center MM, Ferlay J, Ward E, Forman D: Global cancer statistics. CA Cancer J Clin 2011, 61:69-90.
• [2]Govindan R, Bogart J, Vokes EE: Locally Advanced Non-small Cell Lung Cancer: The Past, Present, and Future. J Thorac Oncol 2008, 3:917-928.
• [3]Reinfuss M, Glinski B, Kowalska T, Kulpa J, Zawila K, Reinfuss K, Dymek P, Herman K, Skolyszewski J: Radiotherapy for stage III, inoperable, asymptomatic small cell lung cancer. Final results of a prospective randomized study (240 patients). Cancer Radiother 1999, 3(6):475-479.
• [4]Sause W, Kolesar P, Taylor S, Johnson D, Livingston R, Komaki R, Emami B, Curran W Jr, Byhardt R, Dar AR, Turrisi A: Final Results of Phase III Trial in Regionally Advanced Unresectable Non-Small Cell Lung Cancer. Chest 2000, 117:358-364.
• [5]Auperin A, Le Pe’choux C, Rolland E, Curran WJ, Furuse K, Fournel P, Belderbos J, Clamon G, Ulutin HC, Paulus R, Yamanaka T, Bozonnat MC, Uitterhoeve A, Wang X, Stewart L, Arriagada R, Burdett S, Pignon JP: Meta-Analysis of Concomitant Versus Sequential Radiochemotherapy in Locally Advanced Non–Small-Cell Lung Cancer. J Clin Oncol 2010, 28:2181-2190.
• [6]O’Rourke N, Roqué I, Figuls M, Farré Bernadó N, Macbeth F: Concurrent chemoradiotherapy in non-small cell lung cancer. Cochrane Database Syst Rev 2010, 16(6):CD002140.
• [7]Yamamoto N, Nakagawa K, Nishimura Y, Tsujino K, Satouchi M, Kudo S, Hida T, Kawahara M, Takeda K, Katakami N, Sawa T, Yokota S, Seto T, Imamura F, Saka H, Iwamoto Y, Semba H, Chiba Y, Uejima H, Fukuoka M: Phase III study comparing second- and third-generation regimens with concurrent thoracic radiotherapy in patients with unresectable stage III non–small-cell lung cancer: West Japan Thoracic Oncology Group WJTOG0105. J Clin Oncol 2010, 28:3739-3745.
• [8]Segawa Y, Kiura K, Takigawa N, Kamei H, Harita S, Hiraki S, Watanabe Y, Sugimoto K, Shibayama T, Yonei T, Ueoka H, Takemoto M, Kanazawa S, Takata I, Nogami N, Hotta K, Hiraki A, Tabata M, Matsuo K, Tanimoto M: Phase III trial comparing docetaxel and cisplatin combination chemotherapy with mitomycin, vindesine, and cisplatin combination chemotherapy with concurrent thoracic radiotherapy in locally advanced non-small-cell lung cancer: OLCSG 0007. J Clin Oncol 2010, 28:3299-3306.
• [9]Ichinose Y, Seto T, Sasaki T, Yamanaka T, Okamoto I, Takeda K, Tanaka M, Katakami N, Sawa T, Kudoh S, Saka H, Nishimura Y, Nakagawa K, Fukuoka M: S-1 plus cisplatin with concurrent radiotherapy for locally advanced non-small cell lung cancer: a multi-institutional phase II trial (West Japan Thoracic Oncology Group 3706). J Thorac Oncol 2011, 6(12):2069-2075.
• [10]Sekine I, Noda K, Oshita F, Yamada K, Tanaka M, Yamashita K, Nokihara H, Yamamoto N, Kunitoh H, Ohe Y, Tamura T, Kodama T, Sumi M, Saijo N: Phase I study of cisplatin, vinorelbine, and concurrent thoracic radiotherapy for unresectable stage III non-small cell lung cancer. Cancer Sci 2004, 95(8):691-695.
• [11]Naito Y, Kubota K, Nihei K, Fujii T, Yoh K, Niho S, Goto K, Ohmatsu H, Saijo N, Nishiwaki Y: Concurrent chemoradiotherapy with cisplatin and vinorelbine for stage III non-small cell lung cancer. J Thorac Oncol 2008, 3(6):617-622.
• [12]Nishimura Y, Harada H, Soejima T, Tsujino K, Hayakawa K, Kozuka T, Tanaka M, Sasaki T, Yamamoto N, Nakagawa K: Phase II study of Nimotuzumab in combination with concurrent chemoradiation therapy (CRT) in patients with locally advanced Non-small Cell Lung Cancer (NSCLC). Int J Radiat Oncol Biol Phys 2012, 84(3):S68.
• [13]McAleer MF, Moughan J, Byhardt RW, Cox JD, Sause WT, Komaki R: Does response to induction chemotherapy predict survival for locally advanced non-small cell lung cancer? Secondary analysis of RTOG 8804/8808. Int J Radiat Oncol Biol Phys 2010, 76(3):802-808.
• [14]Kim DW, Shyr Y, Shaktour B, Akerley W, Johnson DH, Choy H: Long term follow up and analysis of long term survivors in patients treated with paclitaxel-based concurrent chemo/radiation therapy for locally advanced non-small cell lung cancer. Lung Cancer 2005, 50:235-245.
• [15]Mauguen A, Pignon JP, Burdett S, Domerg C, Fisher D, Paulus R, Mandrekar SJ, Belani CP, Shepherd FA, Eisen T, Pang H, Collette L, Sause WT, Dahlberg SE, Crawford J, O’Brien M, Schild SE, Parmar M, Tierney JF, Le Pechoux C, Michiels S: Surrogate Lung Project Collaborative Group. Surrogate endpoints for overall survival in chemotherapy and radiotherapy trials in operable and locally advanced lung cancer: a re-analysis of meta-analyses of individual patients’ data. Lancet Oncol 2013, 14(7):619-626.
• [16]Bradley JD, Paulus R, Komaki R, Masters GA, Forster K, Schild SE, Bogart J, Garces YI, Narayan S, Kavadi V, Nedzi LA, Michalski JM, Johnson D, MacRae RM, Curran WJ, Choy H: A randomized phase III comparison of standard-dose (60 Gy) versus high-dose (74 Gy) conformal chemoradiotherapy with or without cetuximab for stage III non-small cell lung cancer: Results on radiation dose in RTOG 0617. J Clin Oncol 2013, 31(15):7501.