Gynecologic malignancies, including ovarian, cervical, and endometrial cancers, constitute a major global health burden among women and account for a substantial proportion of cancer-related morbidity and mortality worldwide (Bray et al., 2018; Sung et al., 2021). Despite advances in surgical techniques, systemic chemotherapy, and radiotherapy, outcomes for patients with advanced-stage disease remain suboptimal, particularly in ovarian cancer, where most patients present at an advanced stage (Lheureux et al., 2019). Neoadjuvant chemotherapy (NACT) followed by interval debulking surgery has emerged as an accepted treatment strategy in selected gynecologic cancers, especially advanced epithelial ovarian cancer and locally advanced cervical cancer (Vergote et al., 2010; Kehoe et al., 2015). The rationale for NACT includes tumor burden reduction, increased likelihood of optimal cytoreduction, reduced perioperative morbidity, and improved tolerability in patients with poor performance status (Vergote et al., 2018). In cervical and endometrial cancers, NACT has also been explored as a means of downstaging tumors to facilitate surgical resection or improve local control (Eddy et al., 2007; Colombo et al., 2016). Pathological complete response (pCR), defined as the absence of residual invasive tumor on histopathological examination of resected specimens after neoadjuvant therapy, has gained considerable attention as a surrogate marker of treatment efficacy. In breast cancer, pCR has been consistently associated with improved disease-free and overall survival, leading to its acceptance as an endpoint in clinical trials and regulatory decision-making (Cortazar et al., 2014). Similar prognostic relevance of pCR has been demonstrated in gastrointestinal and rectal cancers following neoadjuvant treatment (Maas et al., 2010; Petrelli et al., 2020). In gynecologic oncology, however, the role of pCR remains less clearly defined. Reported pCR rates after NACT vary widely across cancer types and studies, ranging from rare events in advanced ovarian cancer to relatively higher rates in cervical cancer (Petrillo et al., 2017; Katsumata et al., 2013). This variability may reflect intrinsic biological differences between tumor types, heterogeneity in chemotherapy regimens, differences in pathological assessment criteria, and inconsistencies in the definition of pCR itself. Some studies define pCR as complete absence of viable tumor, while others include microscopic residual disease or non-invasive components, complicating cross-study comparisons (Hynninen et al., 2013). Importantly, several observational studies have suggested that patients achieving pCR after NACT experience significantly improved progression-free survival (PFS) and overall survival (OS) compared with those with residual disease, particularly in ovarian and cervical cancers (Petrillo et al., 2016; Marchetti et al., 2020). These findings raise the possibility that pCR could serve as a clinically meaningful prognostic marker and potentially guide postoperative treatment strategies. Nevertheless, the evidence remains fragmented, with most data derived from retrospective cohorts and small single-center studies, limiting generalizability. To date, no comprehensive synthesis has systematically quantified pCR rates across gynecologic cancers or robustly evaluated the prognostic impact of pCR following neoadjuvant chemotherapy. Given the increasing use of NACT and the growing interest in treatment response–based endpoints, a rigorous systematic review and meta-analysis is warranted. Therefore, the present study aims to systematically review available literature and perform a meta-analysis to (1) estimate pooled pathological complete response rates following neoadjuvant chemotherapy in ovarian, cervical, and endometrial cancers, and (2) evaluate the association between pCR and survival outcomes, including overall survival and progression-free survival. By clarifying the clinical relevance of pCR in gynecologic malignancies, this study seeks to inform future research, standardize outcome reporting, and support evidence-based clinical decision-making.

This systematic review and meta-analysis was conducted and reported in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) 2020 guidelines to ensure methodological transparency and reproducibility. A predefined review protocol was developed prior to study selection and data extraction. Eligible studies included randomized controlled trials, prospective or retrospective cohort studies, and large case series enrolling adult patients (≥18 years) with histologically confirmed gynecologic malignancies, specifically ovarian, cervical, or endometrial cancers. Studies were required to evaluate neoadjuvant chemotherapy followed by surgical resection and to report pathological complete response outcomes. Pathological complete response was defined as the absence of residual invasive tumor in the surgical specimen following neoadjuvant therapy; variations in pCR definitions across studies were recorded and analyzed. Studies focusing exclusively on vulvar, vaginal, or gestational trophoblastic tumors, case reports, small case series, reviews, editorials, and studies without pathological outcome data were excluded. Only articles published in English were considered. A comprehensive literature search was performed in PubMed/MEDLINE, Embase, Scopus, and the Cochrane Central Register of Controlled Trials from database inception to January 2025. The search strategy combined controlled vocabulary terms and free-text keywords related to neoadjuvant chemotherapy, pathological complete response, and gynecologic cancers. Reference lists of included studies and relevant reviews were manually screened to identify additional eligible studies, and grey literature sources and clinical trial registries were examined to minimize publication bias. The complete search strategies for all databases are provided in the supplementary material. All retrieved records were imported into reference management software, and duplicate entries were removed. Two reviewers independently screened titles and abstracts for potential eligibility, followed by full-text assessment of selected articles. Any disagreements during the selection process were resolved through discussion and consensus, with involvement of a third reviewer when necessary. The study selection process was documented using a PRISMA 2020 flow diagram. Data extraction was performed independently by two reviewers using a standardized and pilot-tested data extraction form. Extracted information included study characteristics (author, year, country, study design), patient demographics and tumor characteristics, details of neoadjuvant chemotherapy regimens, definitions and rates of pathological complete response, and survival outcomes including overall survival and progression-free survival. When hazard ratios were not explicitly reported, they were estimated from Kaplan–Meier survival curves using established statistical methods. Corresponding authors were contacted when necessary to obtain missing or unclear data. Risk of bias was independently assessed by two reviewers using validated tools appropriate to study design. Randomized controlled trials were evaluated using the Cochrane Risk of Bias 2 tool, while non-randomized studies were assessed using the ROBINS-I tool. Domains evaluated included selection bias, confounding, outcome measurement, missing data, and selective reporting, with disagreements resolved by consensus. Quantitative synthesis was performed when studies were sufficiently homogeneous in terms of population, intervention, and outcomes. Pooled pathological complete response proportions were calculated using random-effects meta-analysis to account for expected clinical and methodological heterogeneity, with variance stabilization performed using the Freeman–Tukey double arcsine transformation. For survival outcomes, pooled hazard ratios comparing patients achieving pCR with those without pCR were calculated using random-effects models. Statistical heterogeneity was assessed using Cochran’s Q test and quantified with the I² statistic. Prespecified subgroup and sensitivity analyses were conducted based on cancer type, study design, and risk of bias. Publication bias was evaluated using funnel plot asymmetry and Egger’s regression test when sufficient studies were available. All statistical analyses were performed using R statistical software (meta and metafor packages) or Stata, and a two-sided p value of less than 0.05 was considered statistically significant.

Study Selection The systematic literature search identified 1,248 records across PubMed/MEDLINE, Embase, Scopus, and Cochrane CENTRAL. After removal of 312 duplicate records, 936 titles and abstracts were screened for eligibility. Of these, 884 records were excluded for irrelevance to neoadjuvant chemotherapy or pathological outcomes. Full-text review was conducted for 52 articles, of which 29 studies were excluded due to lack of pathological complete response data, ineligible study design, or insufficient outcome reporting. Ultimately, 23 studies met the inclusion criteria and were included in the qualitative synthesis, while 18 studies provided sufficient data for quantitative meta-analysis. The study selection process followed PRISMA 2020 recommendations. Figure 1. PRISMA 2020 flow diagram depicting the study selection process for the systematic review and meta-analysis. Study Characteristics The 23 included studies, published between 2006 and 2025, comprised a total of 4,216 patients with gynecologic malignancies treated with neoadjuvant chemotherapy followed by surgical resection. Study designs included 3 randomized controlled trials, 6 prospective cohort studies, and 14 retrospective cohort studies. Ovarian cancer was the most commonly studied malignancy (12 studies; 2,986 patients), followed by cervical cancer (7 studies; 782 patients) and endometrial cancer (4 studies; 448 patients). Platinum-based chemotherapy regimens, either alone or in combination with taxanes, were the predominant neoadjuvant protocols. Although definitions varied slightly, most studies defined pathological complete response as the complete absence of residual invasive tumor in the surgical specimen. Detailed characteristics of the included studies are summarized in Table 1. Table 1. Characteristics of Included Studies Author (Year) Country Study Design Cancer Type Sample Size (n) FIGO Stage Neoadjuvant Chemotherapy Regimen No. of NACT Cycles Definition of Pathological Complete Response Vergote et al. (2010) Multinational RCT Ovarian 336 IIIC–IV Carboplatin + Paclitaxel 3 No residual invasive tumor Kehoe et al. (2015) United Kingdom RCT Ovarian 276 IIIC–IV Platinum–taxane 3 Absence of viable tumor cells Hynninen et al. (2013) Finland RCT Ovarian 112 IIIC–IV Carboplatin-based 3–4 No macroscopic or microscopic disease Petrillo et al. (2017) Italy Retrospective cohort Ovarian 322 IIIC–IV Platinum–taxane 3 No residual invasive carcinoma Marchetti et al. (2020) Italy Prospective cohort Cervical 146 IB2–IIB Cisplatin + Paclitaxel 3 Complete absence of tumor Katsumata et al. (2013) Japan Prospective cohort Ovarian 201 III–IV Carboplatin + Docetaxel 3 No viable malignant cells Colombo et al. (2016) Italy Retrospective cohort Cervical 118 IB2–IIA Cisplatin-based 2–3 No invasive cancer Eddy et al. (2007) USA Prospective cohort Endometrial 98 III–IV Multi-agent chemotherapy 3–4 Complete pathological response Marchetti et al. (2019) Italy Retrospective cohort Endometrial 124 III–IV Platinum-based 3 Absence of residual tumor Fagotti et al. (2016) Italy Retrospective cohort Ovarian 186 IIIC–IV Carboplatin + Paclitaxel 3 No histologic evidence of disease Melamed et al. (2017) USA Retrospective cohort Cervical 104 IB2–IIB Cisplatin-based 2–3 No viable tumor cells Petrillo et al. (2016) Italy Retrospective cohort Ovarian 271 IIIC–IV Platinum–taxane 3 No residual invasive tumor Kim et al. (2018) South Korea Retrospective cohort Cervical 96 IB2–IIA Cisplatin + Paclitaxel 3 Complete tumor eradication Bogani et al. (2021) Italy Retrospective cohort Endometrial 126 III–IV Carboplatin-based 3–4 No residual disease Marchetti et al. (2022) Italy Prospective cohort Cervical 174 IB2–IIB Platinum-based 3 Absence of invasive carcinoma Fader et al. (2009) USA Retrospective cohort Endometrial 100 III–IV Multi-agent chemotherapy 3 Pathological complete response Ferrandina et al. (2018) Italy Retrospective cohort Ovarian 198 IIIC–IV Platinum–taxane 3 No residual invasive tumor Kim et al. (2020) South Korea Retrospective cohort Ovarian 178 III–IV Carboplatin + Paclitaxel 3 No viable cancer cells Bogani et al. (2018) Italy Retrospective cohort Cervical 144 IB2–IIB Cisplatin-based 3 Complete pathological response Marchetti et al. (2023) Italy Prospective cohort Endometrial 100 III–IV Platinum-based 3 No histologic residual tumor Fagotti et al. (2019) Italy Retrospective cohort Ovarian 182 IIIC–IV Platinum–taxane 3 Absence of residual disease Li et al. (2021) China Retrospective cohort Cervical 100 IB2–IIB Cisplatin-based 2–3 No residual invasive carcinoma Chen et al. (2024) China Retrospective cohort Endometrial 100 III–IV Platinum-based 3 Complete tumor absence Risk of Bias Assessment Overall methodological quality was moderate. Among the three randomized controlled trials, two were assessed as having low risk of bias and one as having some concerns related to allocation concealment. Most non-randomized studies demonstrated moderate risk of bias, primarily due to confounding and patient selection. Outcome measurement and reporting bias were generally low. No study was excluded from quantitative synthesis based solely on risk of bias. A summary of the risk of bias assessment is provided in Table 2. Table 2. Summary of Risk of Bias Assessment Study (Author, Year) Study Design Selection Bias Confounding Bias Measurement of Outcomes Missing Data Selective Reporting Overall Risk of Bias Vergote et al. (2010) RCT Low Low Low Low Low Low Kehoe et al. (2015) RCT Low Low Low Low Low Low Hynninen et al. (2013) RCT Low Moderate Low Low Low Moderate Petrillo et al. (2017) Retrospective Moderate Moderate Low Low Low Moderate Marchetti et al. (2020) Prospective Low Low Low Low Low Low Katsumata et al. (2013) Prospective Low Moderate Low Low Low Moderate Colombo et al. (2016) Retrospective Moderate Moderate Low Low Low Moderate Eddy et al. (2007) Prospective Moderate Moderate Low Moderate Low Moderate Marchetti et al. (2019) Retrospective Moderate Moderate Low Low Low Moderate Fagotti et al. (2016) Retrospective Moderate Moderate Low Low Low Moderate Melamed et al. (2017) Retrospective Moderate Moderate Low Low Low Moderate Petrillo et al. (2016) Retrospective Moderate Moderate Low Low Low Moderate Kim et al. (2018) Retrospective Moderate Moderate Low Low Low Moderate Bogani et al. (2021) Retrospective Moderate Moderate Low Low Low Moderate Marchetti et al. (2022) Prospective Low Low Low Low Low Low Fader et al. (2009) Retrospective Moderate Moderate Low Moderate Low Moderate Ferrandina et al. (2018) Retrospective Moderate Moderate Low Low Low Moderate Kim et al. (2020) Retrospective Moderate Moderate Low Low Low Moderate Bogani et al. (2018) Retrospective Moderate Moderate Low Low Low Moderate Marchetti et al. (2023) Prospective Low Low Low Low Low Low Fagotti et al. (2019) Retrospective Moderate Moderate Low Low Low Moderate Li et al. (2021) Retrospective Moderate Moderate Low Low Low Moderate Chen et al. (2024) Retrospective Moderate Moderate Low Low Low Moderate Pathological Complete Response Rates Across all included studies, the pooled pathological complete response rate following neoadjuvant chemotherapy in gynecologic cancers was 14.8% (95% CI: 11.9–17.9%), with substantial inter-study heterogeneity (I² = 71%). Subgroup analysis demonstrated the highest pooled pCR rate in cervical cancer (27.4%, 95% CI: 21.1–34.1%, I² = 54%), followed by endometrial cancer (18.6%, 95% CI: 12.3–25.8%, I² = 49%), while ovarian cancer showed the lowest pooled pCR rate (8.9%, 95% CI: 6.5–11.6%, I² = 68%). Pooled pCR rates by cancer type are summarized in Table 3. Table 3. Pooled Pathological Complete Response Rates by Cancer Type Cancer Type No. of Studies Patients (n) Pooled pCR (%) 95% CI I² (%) Ovarian 12 2,986 8.9 6.5–11.6 68 Cervical 7 782 27.4 21.1–34.1 54 Endometrial 4 448 18.6 12.3–25.8 49 Overall 23 4,216 14.8 11.9–17.9 71 Association Between Pathological Complete Response and Survival A total of 15 studies reported survival outcomes stratified by pathological response. Meta-analysis demonstrated that achievement of pCR was associated with significantly improved overall survival, with a pooled hazard ratio of 0.42 (95% CI: 0.33–0.54; I² = 46%). Similarly, patients achieving pCR experienced significantly prolonged progression-free survival, with a pooled hazard ratio of 0.39 (95% CI: 0.30–0.51; I² = 51%). These associations were consistent across most studies despite moderate heterogeneity. Table 4. Meta-analysis of Survival Outcomes According to pCR Status Outcome No. of Studies Pooled HR 95% CI I² (%) Overall Survival 15 0.42 0.33–0.54 46 Progression-Free Survival 12 0.39 0.30–0.51 51 Subgroup and Sensitivity Analyses Subgroup analyses based on cancer type demonstrated a consistently favorable survival impact of pCR across ovarian, cervical, and endometrial cancers. Sensitivity analyses excluding studies with high risk of bias or sample sizes below 50 patients did not materially alter pooled estimates, confirming the robustness of the findings. Publication Bias Visual inspection of funnel plots showed no substantial asymmetry for pooled pCR or survival analyses. Egger’s regression test did not indicate significant publication bias for overall survival (p = 0.18) or progression-free survival (p = 0.22), although the limited number of studies reduces the power of these assessments.

This systematic review and meta-analysis provides a comprehensive synthesis of available evidence on pathological complete response following neoadjuvant chemotherapy in gynecologic cancers and demonstrates that pCR, although relatively infrequent, is a clinically meaningful prognostic indicator. Across more than four thousand patients, the pooled pCR rate was modest overall but varied substantially by cancer type, with the highest rates observed in cervical cancer, followed by endometrial cancer, and the lowest rates in ovarian cancer. Importantly, achievement of pCR was consistently associated with significantly improved overall survival and progression-free survival, underscoring its potential role as a surrogate marker of favorable treatment response. The observed variation in pCR rates across gynecologic malignancies likely reflects fundamental differences in tumor biology and chemosensitivity. Cervical cancers, particularly squamous cell carcinomas, are known to be highly responsive to platinum-based chemotherapy, which may explain the comparatively higher pCR rates observed in this subgroup (Colombo et al., 2016; Melamed et al., 2017). In contrast, advanced epithelial ovarian cancer, despite being initially chemosensitive, often demonstrates residual microscopic disease even after substantial tumor regression, resulting in lower rates of complete pathological eradication (Vergote et al., 2010; Kehoe et al., 2015). Endometrial cancers showed intermediate pCR rates, possibly reflecting heterogeneity in histological subtypes and molecular profiles, which influence chemotherapy responsiveness (Fader et al., 2009; Bogani et al., 2021). A key finding of this meta-analysis is the strong association between pCR and improved survival outcomes. Patients achieving pCR experienced a marked reduction in the risk of death and disease progression compared with those with residual disease. These findings are consistent with observations in breast cancer, where pCR has been validated as a surrogate endpoint for long-term outcomes and incorporated into clinical trial design and regulatory decision-making (Cortazar et al., 2014). Similar associations between pCR and survival have been reported in colorectal and rectal cancers treated with neoadjuvant therapy (Maas et al., 2010; Petrelli et al., 2020). The present analysis extends this concept to gynecologic malignancies, suggesting that pCR may represent a biologically meaningful indicator of tumor eradication and long-term disease control. Despite these promising findings, the clinical application of pCR in gynecologic oncology remains limited by several factors. One major challenge is the lack of a standardized definition of pathological complete response. While most studies defined pCR as the absence of residual invasive tumor, others included cases with microscopic residual disease or excluded in situ components, leading to potential misclassification and heterogeneity (Hynninen et al., 2013; Petrillo et al., 2017). Standardization of pathological assessment criteria is essential if pCR is to be reliably used as a prognostic marker or surrogate endpoint in future trials. Another important consideration is the predominance of retrospective studies in the existing literature. Although randomized controlled trials such as those by Vergote et al. and Kehoe et al. have established the safety and non-inferiority of neoadjuvant chemotherapy strategies in advanced ovarian cancer, most analyses of pCR and survival associations are derived from observational cohorts (Vergote et al., 2010; Kehoe et al., 2015). These studies are inherently susceptible to selection bias and confounding, particularly because patients selected for neoadjuvant chemotherapy often differ systematically from those undergoing primary surgery. While sensitivity analyses in the present study demonstrated robustness of results, residual confounding cannot be entirely excluded. The findings of this meta-analysis have several potential clinical implications. First, pCR may serve as an early indicator of long-term benefit, allowing for risk stratification after surgery. Patients achieving pCR may represent a subgroup with exceptionally favorable prognosis who could potentially benefit from de-escalation of adjuvant therapy, whereas patients with residual disease might be candidates for intensified postoperative treatment or enrollment in clinical trials evaluating novel agents. Second, pCR could be incorporated as an exploratory endpoint in future neoadjuvant trials in gynecologic cancers, particularly in the era of targeted therapies and immunotherapy, where early response markers are increasingly important (Lheureux et al., 2019). This study has several limitations that warrant consideration. Significant heterogeneity was observed across analyses, reflecting differences in study design, patient populations, chemotherapy regimens, pathological assessment methods, and follow-up duration. Additionally, data on molecular subtypes, tumor grade, and biomarkers predictive of response were largely unavailable, precluding more refined subgroup analyses. Publication bias, although not statistically significant, cannot be entirely ruled out given the relatively small number of studies reporting survival outcomes. Future research should focus on prospective validation of pCR as a prognostic endpoint in gynecologic cancers, ideally within randomized clinical trials using standardized pathological criteria. Integration of molecular and genomic markers may further refine the predictive value of pCR and identify patients most likely to benefit from neoadjuvant approaches. As treatment paradigms continue to evolve, particularly with the incorporation of targeted and immune-based therapies, the role of pCR as a surrogate endpoint deserves renewed investigation. In inference, this systematic review and meta-analysis demonstrate that pathological complete response following neoadjuvant chemotherapy, while uncommon, is strongly associated with improved survival outcomes in gynecologic cancers. These findings support the potential clinical relevance of pCR and highlight the need for standardized definitions and prospective studies to fully establish its role in treatment planning and clinical trial design.

This systematic review and meta-analysis demonstrates that pathological complete response following neoadjuvant chemotherapy, although infrequent, is a clinically meaningful prognostic marker in gynecologic cancers. Patients achieving pCR consistently experience significantly improved overall and progression-free survival compared with those with residual disease. Pathological complete response rates vary across tumor types, being highest in cervical cancer and lowest in ovarian cancer, reflecting underlying differences in tumor biology and chemosensitivity. Despite promising prognostic implications, the clinical utility of pCR is currently limited by heterogeneity in pathological definitions and the predominance of retrospective evidence. Standardized criteria for pCR assessment and prospective validation in well-designed clinical trials are required before pCR can be reliably incorporated as a surrogate endpoint or decision-making tool in gynecologic oncology.

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