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Randomized Controlled Trial
. 2022 Dec 5;22(1):1270.
doi: 10.1186/s12885-022-10355-3.

Neoadjuvant chemotherapy for patients with international federation of gynecology and obstetrics stages IB3 and IIA2 cervical cancer: a multicenter prospective trial

Yingjie Hu #  1 , Yingyan Han #  1 , Yuanming Shen #  2 , Jing Chen  1 , Yaheng Chen  1 , Yile Chen  3 , Junying Tang  4 , Min Xue  5 , Li Hong  6 , Wenjun Cheng  7 , Danbo Wang  8 , Zhiqing Liang  9 , Yifeng Wang  10 , Qinghua Zhang  11 , Hui Xing  12 , Yu Zhang  13 , Cunjian Yi  14 , Zhiying Yu  15 , Youguo Chen  16 , Manhua Cui  17 , Cailing Ma  18 , Hongying Yang  19 , Ruizhen Li  20 , Ping Long  21 , Yu Zhao  22 , Pengpeng Qu  23 , Guangshi Tao  24 , Lihua Yang  25 , Sufang Wu  26 , Zhihua Liu  27 , Ping Yang  28 , Weiguo Lv  2 , Xing Xie  2 , Ding Ma  1 , Hui Wang  29 , Kezhen Li  30
Affiliations
Randomized Controlled Trial

Neoadjuvant chemotherapy for patients with international federation of gynecology and obstetrics stages IB3 and IIA2 cervical cancer: a multicenter prospective trial

Yingjie Hu et al. BMC Cancer. .

Abstract

Background: Preoperative neoadjuvant chemotherapy (NACT) has been widely used in developing countries for the treatment of patients with International Federation of Gynecology and Obstetrics (FIGO) stages IB3 and IIA2 cervical cancer. However, the effectiveness of NACT and treatment options for NACT-insensitive patients have been concerning. This study will assess prognostic differences between NACT and primary surgery treatment (PST), determine factors associated with prognosis, and explore better adjuvant treatment modalities for NACT-insensitive patients.

Methods: This study analyzed clinical characteristics, pathological characteristics, treatment options, and follow-up information of 774 patients with FIGO stages IB3 and IIA2 cervical cancer from 28 centers from January 2016 to October 2019 who participated in a multicenter, prospective, randomized controlled trial.

Results: For patients undergoing NACT, the 5-year OS and PFS rate was 85.8 and 80.5% respectively. They were similar in the PST group. There was no significant difference in OS and PFS between clinical response (CR)/partial response (PR) groups and stable disease (SD)/progressive disease (PD) groups. Apart from deep cervical invasion (p = 0.046) affecting OS for patients undergoing NACT, no other clinical and pathological factors were associated with OS. 97.8% of NACT-insensitive patients opted for surgery. If these patients did not have intermediate- or high-risk factors, whether they had undergone postoperative adjuvant therapy was irrelevant to their prognosis, whereas for patients with intermediate- or high-risk factors, adjuvant chemotherapy resulted in better PFS (chemotherapy vs. no therapy, p < 0.001; chemotherapy vs. radiotherapy, p = 0.019) and OS (chemotherapy vs. no therapy, p < 0.001; chemotherapy vs. radiotherapy, p = 0.002).

Conclusions: NACT could be a choice for patients with FIGO stages IB3 and IIA2 cervical cancer. The main risk factor influencing prognosis in the NACT group is deep cervical invasion. After systematic treatment, insensitivity to NACT does not indicate a poorer prognosis. For NACT-insensitive patients, Chinese prefer surgery. Postoperative adjuvant therapy in patients with no intermediate- or high-risk factors does not improve prognosis, and chemotherapy in patients with intermediate- and high-risk factors is more effective than radiation therapy and other treatments.

Trial registration: The study was prospectively registered on ClinicalTrials.gov (NCT03308591); date of registration: 12/10/2017.

Keywords: Cervical cancer; Neoadjuvant chemotherapy; Non-responders; Prognosis; Radical surgery.

PubMed Disclaimer

Conflict of interest statement

The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.

Figures

Fig. 1
Fig. 1
Flow Diagram of Patient Selection. Abbreviations: NACT, neoadjuvant therapy; PST, primary surgical treatment; CR, clinical response; PR, partial response; SD, stable disease; PD, progressive disease
Fig. 2
Fig. 2
Progression Free Survival and Overall Survival Curves in Intention-to-Treat and Per-Protocol Populations. Kaplan–Meier plot for (A) progression free survival and (B) overall survival compared between NACT and PST in ITT population, and (C) PFS and (D) OS in PP population. The hazard ratio, 95% confidence interval, and corresponding p-value were estimated by Cox proportional-hazards models. Tick marks indicate censored data. Abbreviations: NACT, neoadjuvant therapy; PST, primary surgical treatment; PFS, progression free survival; OS, overall survival; ITT, intention-to-treat; PP, per-protocol
Fig. 3
Fig. 3
Progression Free Survival, Overall Survival, and Disease-Specific Survival Curves for Patients Undergoing NACT. Kaplan–Meier plot for (A) progression free survival, (B) overall survival, and (C) disease-specific survival according to the response of cervical cancer patients to chemotherapy. Tick marks indicate censored data. Abbreviations: PFS, progression-free survival; OS, overall survival; DSS, disease-specific survival; CR, clinical response; PR, partial response; SD, stable disease; PD, progressive disease
Fig. 4
Fig. 4
Therapy and Outcomes of Patients Insensitive to NACT. Abbreviations: SD, stable disease; PD, progressive disease; OS, overall survival
Fig. 5
Fig. 5
Progression Free Survival and Overall Survival Curves for Patients Insensitive to NACT. Figure 5 included 91 patients receiving neoadjuvant chemotherapy followed by radical surgery. Log-rank test was used to test the difference in PFS and OS of three interventions, and interventions were compared in pairs as well. Kaplan–Meier plot showed progression free survival and overall survival of all SD/PD population (A and B), of patients in low-risk group (C and D) and in intermediate- and high-risk group (E and F). Tick marks indicate censored data. Abbreviations: PFS, progression free survival; OS, overall survival; CR, clinical response; PR, partial response; SD, stable disease; PD, progressive disease
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