Phase II clinical study of neoadjuvant chemotherapy with CDDP/CPT-11 regimen in combination with radical hysterectomy for cervical cancer with a bulky mass

Abstract

BackgroundWe examined the efficacy and safety of neoadjuvant chemotherapy (NAC) with the CPT-11 + CDDP regimen in combination with radical hysterectomy.Subjects and methodsThe subjects were 42 patients with stages IB2 to IIIB squamous cell carcinoma of the uterine cervix with a bulky mass. CDDP at 70 mg/m2 was intravenously administered on day 1 and CPT-11 at 70 mg/m2 was intravenously administered on days 1 and 8 of a 21-day cycle. In principle, two cycles were administered followed by radical hysterectomy. We examined antitumor efficacy, adverse events, completion rate of radical hysterectomy, operative time, surgical blood loss, progression-free survival (PFS), and overall survival (OS).ResultsThe antitumor effect was complete response in 7 patients, partial response in 28, stable disease in 6, and progressive disease in 1; the response rate was 83.3 % (95 % confidence interval, 68.6–93.0). Grade 3 or more severe neutropenia, anemia, and platelet count decreases were noted in 23 (54.8 %), 4 (9.5 %), and 1 (2.4 %) patient, respectively. Grade 3 nausea occurred in 3 patients (7.1 %), vomiting in 1 (2.4 %), and grade 3 febrile neutropenia in 2 (7.1 %). The completion rate of radical hysterectomy was 88.1 %. The median operative time and surgical blood loss were 260 min (range, 210–334) and 500 ml (range, 393–898), respectively. The 5-year PFS rate was 67.2 %, and the 5-year OS rate was 68.0 %. In multivariate analysis, lymph node metastasis before NAC [hazard ratio (HR), 34.88] and non-response to NAC (HR 30.58) were significant prognostic factors.ConclusionNAC with the CDDP/CPT-11 regimen achieves a high antitumor efficacy with moderate adverse reactions, allowing safe radical hysterectomy, and is thus considered to be a useful therapeutic method that can improve prognosis.

Postoperative Adjuvant Chemotherapy in Locally Advanced Cervical Cancer Patients with Optimal Response to Neoadjuvant Chemotherapy: A Retrospective Study

“…However, we noticed that the recurrence rate (13.3%) in patients without therapy in our study is higher than European studies (range 10.9%-11.1%) [4,13]. The possible explanation is the different NACT cycle because in Asian countries, such as China and Japan, 2 cycles of platinum-based NACT were widely accepted for patients [11,12,[15][16][17], whereas 3 cycles were widely used in European countries [4,7,18].…”

Meta-analysis showing that early response to neoadjuvant chemotherapy predicts better survival among cervical cancer patients

“…Another 12 articles were excluded from further analysis because they did not evaluate clinical response but only pathological response. Three studies were excluded because the data of CR/PR versus PD/SD cannot be extracted [ 3 , 27 , 28 ]. Finally eight studies were included in the final analysis [ 17 , 18 , 29 – 34 ].…”

“…According to the latest report, there are 527,600 new cases and 265,700 deaths across the world every year [ 1 ]; there were 98,900 new cases in China in 2015 [ 2 ]. NACT plus surgery, has emerged as a new hope for cervical cancer patients [ 3 – 5 ] and an alternative to traditional therapies, such as radiotherapy or concurrent chemoradiotherapy. First, NACT often reduces tumor size [ 6 ], eliminates distant micro-metastasis, and thus makes surgery easier [ 7 – 9 ].…”

UGT1A1 polymorphism has a prognostic effect in patients with stage IB or II uterine cervical cancer and one or no metastatic pelvic nodes receiving irinotecan chemotherapy

“…Takekuma et al reported that chemotherapy after surgery for high-risk patients had similar e cacy and a different toxicity pro le from that of CCRT, associated with worse toxicity than chemotherapy [9]. In Japan, phase II trials have been conducted to determine the e cacy and toxicity of neoadjuvant chemotherapy (NAC) with irinotecan (CPT-11) and nedaplatin (NDP) followed by radical hysterectomy and adjuvant chemotherapy for locally advanced, bulky stage IB2-IIB cervical cancer [10][11][12][13].…”