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Neoadjuvant chemoradiotherapy combined with total mesorectal excision is the standard treatment for stage T 3-T 4/N+ locally advanced rectal cancer (LARC). However, proctectomy is burdened with consistent postoperative morbidity, severely affecting the quality of life. "Organ preserving" methods could achieve similar oncological outcomes in highly selected patients whose tumors demonstrate (almost) clinical complete response to neoadjuvant treatment, while maintaining the quality of life and anorectal function by keeping the anus. This article aims to summarize the strategies of organ preservation after neoadjuvant treatment of LARC, salvage treatment for regrowth or recurrence, and anorectal function after organ preservation strategies.
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Some patients with rectal cancer can achieve clinical complete response (cCR) after neoadjuvant chemoradiotherapy. The watch and wait strategy for cCR patients can achieve similar curative effects as radical surgery, avoid surgical complications, and significantly improve the quality of life of patients, which is attracting increasing attention. Although the existing research results support that the watch and wait strategy is safe and feasible, there is still a lack of high-level evidence-based medicine evidence. There are still many issues in the implementation of the watch and wait strategy that need to be further clarified, including long-term oncology efficacy, cCR diagnosis and evaluation criteria, appropriate patient selection, follow-up strategies during the observation period, and treatment methods for local tumor regeneration. This article will explain the above problems based on the results of the existing literature and the clinical experience of our center.
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Objective: Total neoadjuvant chemoradiotherapy is one of the standard treatments for locally advanced rectal cancer. This study aims to investigate the safety and feasibility of programmed cell death protein 1 (PD-1) antibody combined with total neoadjuvant chemoradiotherapy in the treatment of locally advanced middle-low rectal cancer with high-risk factors. Methods: A descriptive cohort study was conducted. Clinicopathological data of 24 patients with locally advanced middle-low rectal cancer with high-risk factors receiving PD-1 antibody combined with neoadjuvant chemoradiotherapy in Gastrointestinal Cancer Center, Unit III, Peking University Cancer Hospital between January 2019 and April 2021 were retrospectively analyzed. Inclusion criteria: (1) rectal adenocarcinoma confirmed by pathology; patient age of ≥ 18 years and ≤ 80 years; (2) the distance from low margin of tumor to anal verge ≤ 10 cm under sigmoidoscopy; (3) ECOG performance status score 0-1; (4) clinical stage T3c, T3d, T4a or T4b, or extramural venous invasion (EMVI) (+) or mrN2 (+) or mesorectal fasciae (MRF) (+) based on MRI; (5) no evidence of distant metastases; (6) no prior pelvic radiation therapy, no prior chemotherapy or surgery for rectal cancer; (7) no systemic infection requiring antibiotic treatment and no immune system disease. Exclusion criteria: (1) anticipated unresectable tumor after neoadjuvant treatment; (2) patients with a history of a prior malignancy within the past 5 years, or with a history of any arterial thrombotic event within the past 6 months; (3) patients received other types of antitumor or experimental therapy; (4) women who were pregnant or breast-feeding; (5) patients with any other concurrent medical or psychiatric condition or disease; (6) patients received immunotherapy (PD-1 antibody). The neoadjuvant therapy consisted of three stages: PD-1 antibody (sintilimab 200 mg, IV, Q3W) combined with CapeOx regimen for three cycles; long-course intensity modulated radiation therapy (IMRT) with gross tumor volume (GTV) 50.6 Gy/CTV 41.8 Gy/22f; CapeOx regimen for two cycles after radiotherapy. After oncological evaluation following the end of the third stage of treatment, surgery or watch and wait would be carried out. Surgical safety, histopathological changes and short-term oncological outcome were analyzed. Results: There were 15 males and 9 females with a median age of 65 (47-78) years. Median distance from the lower margin of the tumor to the anal verge was 4 (3-7) cm. The median maximal diameter of the tumor was 5.1 (2.1-7.5) cm. Twenty patients were cT3, 4 were cT4, 8 were cN1, 5 were cN2a, 11 were cN2b. Ten cases were MRF (+) and 10 were EMVI (+). All the patients were mismatch repair proficient (pMMR). During the neoadjuvant treatment period, 6 patients (25.0%) developed grade 1-2 treatment-related adverse events, including 3 immune-related adverse events. As of April 30, 2021, 20 patients (83.3%, 20/24) had received surgical resection, including 19 R0 resections and 16 sphincter-preservation operations. Morbidity of postoperative complication was 25.0% (5/20), including 2 cases of Clavien-Dindo grade II (1 of anastomotic bleeding and 1 of pseudomembranous enteritis), 3 cases of grade I anastomotic stenosis. Pathological complete response (pCR) rate was 30.0% (6/20) and major pathological response rate was 20.0% (4/20). None of Ras/Raf mutants had pCR or cCR (0/5), while 6 of 17 Ras/Raf wild-type patients had pCR and 3 had cCR, which was significantly higher than that of Ras/Raf mutants (P<0.01). Nine of 16 patients with Ras/Raf wild-type and differentiated adenocarcinoma had pCR or cCR. Among other 4 patients without surgery, 3 patients preferred watch and wait strategy because their tumors were assessed as clinical complete response (cCR), while another one patient refused surgery as the tumor remained stable. After a median follow-up of 11 (6-24) months, only 1 patient with signet ring cell carcinoma had recurrence. Conclusions: PD-1 antibody combined with total neoadjuvant chemoradiotherapy in the treatment of locally advanced rectal cancer has quite good safety and histopathological regression results. Combination of histology and genetic testing is helpful to screen potential beneficiaries.
Subject(s)
Aged , Female , Humans , Male , Middle Aged , Antineoplastic Combined Chemotherapy Protocols , Apoptosis , Chemoradiotherapy , Neoadjuvant Therapy , Neoplasm Recurrence, Local , Programmed Cell Death 1 Receptor/antagonists & inhibitors , Rectal Neoplasms/therapy , Retrospective Studies , Risk Factors , Treatment OutcomeABSTRACT
Patients with clinical complete response(cCR) after neoadjuvant treatment receiving the Watch and Wait('W&W’) policy can achieve similar survival of those with yeild pathological complete response (ypCR), and have significantly improved quality of life compared to those undergoing radical operation. Based on thoroughly reviewing the literatures and guidelines at home and abroad, and referring associated clinical experiences from a lot of domestic medical centers, the present version of Chinese Consensus on W&W was established by a panel of many experts of gastrointestinal surgery, medical oncology, radiation oncology, pathology, endoscopy, radiology. This consensus mainly elucidates important conceptions of the W&W policy, current key evidences, risks and benefits for patients, conditions to carry out W&W, criteria of cCR diagnosis, timing of evaluation, follow - up plan, salvage treatment for local relapse and distant metastasis, associated problems of local resection, and is expected to facilitate the clinical practice and research of W&W policy in China.
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Objective@#To preliminarily explore the value of transanal endoscopic microsurgery (TEM) in rectal cancer patients with clinical complete response (cCR) following neoadjuvant chemoradiotherapy (nCRT).@*Methods@#Using descriptive case series method, Clinical data of 13 patients who met the criteria of nCRT and were considered to be cCR after MRI or CT scanning, digital rectal examination and colonoscopic biopsy, as well as no lymph node or distant metastasis were found, then underwent TEM from 2013 to 2016 at the Department of General Surgery of Peking Union Medical College Hospital were collected retrospectively. A 3-course combination of capecitabine and oxaliplatin (XELOX) was used for chemotherapy. Besides, a 6MV-X ray radiation was used as radiotherapy simultaneously. Six to eight weeks after completion of radiotherapy, a preoperative assessment was carried out with intrarectal ultrasound, MRI, or pelvic abdominal CT examination. TEM was performed afterwards with informed consent. Postoperative pathological findings and follow-up results were used to evaluate the value of diagnosis and treatment of TEM on those patients.@*Results@#There were 8 males and 5 females with a median age of 63 (27-80) years. Preoperative examination showed that the lesions were located in the anterior wall in 3 cases, the posterior wall in 3 cases, the left side wall in 4 cases, and the right side wall in 3 cases. Before nCRT, the distance between tumor and anal margin was (4.8±1.1) (2.0-7.5) cm; after nCRT, this distance was (5.2±1.3) (3.0-7.5) cm. All the 13 patients underwent extended local resection of rectal cancer via TEM with the placement of urethral catheter. The average operative time was (52.2±3.7) (42-70) minutes, and the average intraoperative blood loss was (19.2±2.8) (5-30) ml. All the patients could engage in daily activities on postoperative day 1, and could cater themselves orally on postoperative day 2. The main discomfort was postoperative anal pain and foreign body sensation (n=5), which could be alleviated by non-steroidal anti-inflammatory drugs. One case had postoperative lung infection and was cured by antibiotic treatment. One case had urinary retention after removing urine catheter, and then a urine catheter was re-inserted. Average postoperative hospital stay was (2.8±2.4) (2-12) days. All specimens were completely resected via TEM. Histopathological examination confirmed that 7 specimens had achieved pathologic complete response (pCR) and the other 6 specimens had obtained partial tumor response of CAP grade 2. Seven patients with pCR received a median follow-up of 24 (8-48) months and no local recurrence or distant metastasis was reported during follow-up period. Among these 7 cases, one developed defecation dysfunction after discharge, mainly for defecation pain and even dare to defecate, who returned to normal defecation within 2 months after surgery; One developed severe anal pain within six months after surgery and the pain disappeared after symptomatic pain relief. The other 6 patients with CAP grade 2 refused to undergo further radical operation because of their strong desire in preserving anus, and received remedial adjuvant chemotherapy instead.@*Conclusion@#For rectal cancer patients with cCR after nCRT, TEM does have certain application values if the patient has a strong desire to preserve anus.
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Objective@#To understand the perceptions, attitudes and treatment selection of Chinese surgeons on the "watch and wait" strategy for rectal cancer patients after achieving a clinical complete response (cCR) following neoadjuvant chemoradiotherapy (nCRT).@*Methods@#A cross-sectional survey was used in this study. Selection of subjects: (1) Domestic public grade III A (provincial and prefecture-level) oncology hospitals or general hospitals possessing the radiotherapy department and the diagnosis and treatment qualifications for colorectal cancer. (2) Surgeons of deputy chief physician or above. Using the "Questionnaire Star" online survey platform to create a questionnaire about cognition, attitude and treatment choice of the "watch and wait" strategy after cCR following nCRT for rectal cancer. The questionnaire contained 32 questions, such as the basic information of doctor, the current status of rectal cancer surgery, the management of pathological complete remission (ypCR) after nCRT for rectal cancer, the selection of examination items for diagnosis of cCR, the selection of suitable people undergoing "watch and wait" approach, the nCRT mode for promotion of cCR, the choice of evaluation time point, the willingness to perform "watch and wait" approach and the treatment choice, and the risk and monitoring of "watch and wait" approach. A total of 116 questionnaires were sent to the respondents via WeChat between January 31 and February 19, 2019. Statistical analysis was performed using Fisher′s exact test for categorical variables.@*Results@#Forty-eight hospitals including 116 surgeons meeting criteria were enrolled, of whom 77 surgeons filled the questionnaire with a response rate of 66.4%. "Watch and wait" strategy was carried out in 76.6% (59/77) of surgeons. Seventy surgeons (90.9%) were aware of the ypCR rate of rectal cancer after preoperative nCRT and 49 surgeons (63.6%) knew the 3-year disease-free survival of patients with ypCR in their own hospitals. Fifty-five surgeons (71.4%) believed that patients with ypCR undergoing radical surgery met the treatment criteria and were not over-treated. Three most necessary examinations in diagnosing cCR were colonoscopy (96.1%, 74/77), digital rectal examination (DRE) (90.9%,70/77) and DWI-MRI (83.1%, 64/77). Responders preferred to consider a "watch and wait" strategy for patients with baseline characteristics as mrN0 (77.9%, 60/77), mrT2 (68.8%, 53/77) and well-differentiated adenocarcinoma (68.8%, 53/77). Sixty-six surgeons (85.7%) believed that long-term chemoradiotherapy (LCRT) with combination or without combination of induction and/or consolidation of the CapeOX regimen (capecitabine + oxaliplatin) should be the first choice as a neoadjuvant therapy to achieve cCR. Forty-one surgeons (53.2%) believed that a reasonable interval of judging cCR after nCRT should be ≥ 8 weeks. Forty-four surgeons (57.1%) routinely, or in most cases, informed patient the possibility of cCR and proposed to "watch and wait" strategy in the initial diagnosis of patients with non-metastatic rectal cancer. Thirteen surgeons (16.9%) would take the "watch and wait" strategy as the first choice after the patient having cCR. Fifty-two surgeons (67.5%) would be affected by the surgical method, that was to say, "watch and wait" approach would only be recommended to those patients who would achieve cCR and could not preserve the anus or underwent difficult anus-preservation surgery. Sixteen surgeons (20.8%) demonstrated that "watch and wait" strategy would not be recommended to patients with cCR regardless of whether the surgical procedure involved anal sphincter. Eleven surgeons (14.3%) believed that the main risk of "watch and wait" approach came from distant metastasis rather than local recurrence or regrowth. Twenty-nine of surgeons (37.7%) did not understand the difference between "local recurrence" and "local regrowth" during the period of "watch and wait". Twenty-six surgeons (33.8%) thought that the monitoring interval for the first 3 years of "watch and wait" strategy was 3 months, and the follow-up monitoring interval could be 6 months to 5 years. Surgeons from cancer specialist hospitals had higher approval rate, notification rate, and referral rate of "watch and wait" strategy than those from general hospitals. Thirty-one surgeons (42.5%) considered that the difficulty and concern of carrying out "watch and wait" approach in the future was the disease progress leading to medical disputes. Twenty-six surgeons (35.6%) demonstrated that their concern was lack of uniform evaluation standard for cCR.@*Conclusions@#Chinese surgeons seem to have inadequate knowledge of non-operative management for rectal cancer patients achieving cCR after nCRT and show relatively conservative attitudes toward the strategy. Chinese consensus needs to be formed to guide the non-operative management in selected patients. Chinese Watch & Wait Database (CWWD) is also needed to establish and provide more evidence for the use of alternative procedure after a cCR following nCRT.
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Neoadjuvant chemoradiotherapy plus total mesorectal excision (TME) is the standard care for locally advanced middle-low rectal cancer. Some patients could benefit from neoadjuvant chemoradiotherapy to achieve clinical complete response (cCR). Therefore, in recent years, for patients with cCR after neoadjuvant therapy, the "watch and wait" strategy has been widely recommended by their doctors to let them enter "waiting period" without surgery, so that the quality of life is improved. However, the "watch and wait" strategy also has many practical problems that have not been resolved. Firstly, the diagnostic criteria for cCR and pathologic complete response (pCR) are not uniform and different significantly. Secondly, some cCR patients have found tumor regrowth and subsequently underwent salvage surgery during the "watch and wait" period. Thirdly, there is no clinical consensus on the adjuvant therapy for patients during the "watch and wait" period. Fourthly, the role of surgery in patients with cCR is controversial. Finally, we need to accumulate more clinical evidence to confirm whether the "watch and wait" strategy can be selected immediately after achieving cCR for rectal cancer. At the same time, we should find novel molecular markers that can predict the efficacy of chemoradiotherapy. Only rational choice of "watch and wait" strategy will allow more patients with rectal cancer to benefit from chemoradiotherapy.
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A proportion of patients with locally advanced rectal cancer will achieve clinical complete response (cCR) or pathologic complete response (pCR) after neoadjuvant chemoradiotherapy. With the proposal of the concept of total neoadjuvant therapy (TNT), higher complete response rates will be observed. The management of patients with cCR has long been an issue of controversy and is attractive for clinical trials. A "watch and wait" strategy for patients with cCR has been put forward by some scholars. A non-operative approach can preserve the organfunction and avoid complications after radical surgery. The safety and feasibility of a "watch and wait" strategy have been established in several non-randomized controlled studies. There is no consensus on how to make an optimal decision for patients with cCR. For example, it is only observed in partial patients that cCR is consistent with pCR and the molecular biomarkers for predicting pCR are suboptimal. Besides, cCR is inconsistently defined and surveillance recommendations varies. Furthermore, there are insufficient high-level evidence for the "watch and wait" strategy. For patients with good response after chemoradiotherapy, local excision is an attractive alternative to total mesorectal excision, however with uncertain indications and challenged oncological safety. For patients with cCR, we implement the therapeutic principles of goal-orientation, layered treatment and the whole process management.
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OBJECTIVE: To offer some important insights into clinical decision-making by evaluating endorectal ultrasound and rectal MRI when they were used to predict pathological complete response for rectal cancer patients who were performed neoadjuvant therapy. METHODS: The study was a prospective cohort study which was conducted at a single tertiary care center. Patients diagnosed with mid-low rectal cancer between May 2014 and June 2018 in Peking Union Medical College Hospital were collected in the study. Both of their endorectal ultrasound and rectal MRI were performed to evaluate the tumor stage before their preoperative chemoradiation and were reevaluated at the 6 to 7 th weeks after their preoperative radiation treatment. The pathological preoperative tumor staging achieved by endorectal ultrasound and rectal MRI was compared with postoperative staging by pathologic examination. Sensitivity,specificity,accuracy and Youden index of each evaluation method and their combination were calculated. The ROC curve was administered likewise. RESULTS: A total of 247 patients were enrolled in the study. The sensitivity,specificity,accuracy,positive predictive value,negative predictive value and Youden index for ypT0 N0 separate evaluation of for whom was qualified as compete endorectal ultrasound(163 patients) and of rectal MRI(212 patients) was15.9% and 23.1%,94.0% and 94.9%,77.8% and 83.4%,0.1 and 0.2. Combined two methods,the data were recorded as 13.6%,98.1%,83.6% and 0.1.Area under curve ROC for ultrasound and MRI when using specifically for ypT0 N0 measurement was 0.656 and 0.742.The two modalities showed 0.517 and 0.667 in terms of AUC when comparing with each other. CONCLUSION: The sensitivity of MRI and ERUS as terms of diagnosing complete response is rather unsatisfactory,although they all bear a relatively good specificity. For the patients not diagnosed with clinical response by one of the two methods,radical operations were strongly recommended. For the patients confirmed as complete response by both modalities,there still exists possibilities that residual tumor persists,“watch and wait”approach can be taken cautiously and the patient must be followed up intensely.
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Neochemoradiotherapy has been implemented in the multidisciplinary therapy for advanced rectal cancer.The patients with complete response after neothemoradiation could avoid surgical resection and thereafter might be free of surgical complications,as well as functional impairment.However,the preoperative evaluated clinical complete response is not equally to the pathologic complete response after surgery.The accurate methods to evaluate the status of complete response remained controversy.Based on the digital rectal examination and endoscopic observation,rectal MRI and endorectal ultrasound could verify the integrity of mucosa and the structural changes in rectal wall.These preoperative staging methods,as well as PET-CT and needle biopsy,had been widely used,but with a low sensitivity.
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Objective To investigate the feasibility of non-operative management (NOM) by comparing the therapeutic effects between NOM and total mesorectal excision (TME) for rectal cancer patients with clinical complete response (cCR) after neo-adjuvant chemoradiotherapy.Methods A total of 135 patients with stage Ⅱ/Ⅲ rectal cancer who obtained cCR after neo-adjuvant chemoradiotherapy in Sun Yat-sen University Cancer Center from 2006 to 2016 were recruited and assigned into the NOM (n =43) and standard operative management (SOM) groups (n=92).The local recurrence rate,accumulative local control (LC) rate after salvage therapy,disease-free survival (DFS),overall survival (OS) and sphincter preservation rate were statistically compared between two groups.Kaplan-Meier analysis and log-rank test were utilized to calculate the LC,OS and DFS.Chi-square test was performed to calculate the sphincter preservation rate.Results The mean follow-up duration was 39 months (range:10-127 months).Of 135 patients,the local recurrence rate and distant metastasis rate were 3.7％ and 11.1％,and the 3-year DFS and OS were 90.5％ and 97.0％.In the NOM and SOM groups,the 3-year DFS were 87％ and 93％,and the 5-year DFS were 73％ and 87％(P=0.089).The 3-year OS were 98％ and 99％,and the 5-year OS were 98％ and 97％ (P=0.578).In the NOM group,the local recurrence rate was 12％ (n =5),80％ of patients received salvage treatment and the accumulative LC rate was calculated as 98％.In the SOM group,the local recurrence rate was 0,which was significantly lower than that in the NOM group (P=0.O10).In the NOM group,the sphincter preservation rate was 93％,significantly higher compared with 70％ in the SOM group (P=0.030).Conclusions It is feasible for rectal cancer patients with cCR to receive NOM following neo-adjuvant chemoradiotherapy.Partial locally recurrent patients can be healed by timely salvage therapy,thereby averting TME and relevant complications and enhancing the quality of life of rectal cancer patients.
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Neo-adjuvant chemoradiotherapy (NACRT) combined with total mesorectal excision (TME) surgery is the main treatment for locally advanced middle-low rectal cancer, and NACRT significantly improves the local control rate of rectal cancer. According to the current guidelines, patients who receive clinical complete response (cCR) after NACRT are recommended for treatment with TME surgery. A few studies have shown that the watch-and-wait (WAW) policy is safe and could ensure anorectal function and quality of life in patients with cCR. In addition, such patients must be closely observed and followed up so as to enable salvage surgery for long periods of tumor re-growth. However, there is not enough evidence to provide a clear answer to the oncological effect of the WAW policy. As a result, WAW policy is not widely available in clinical practice, and further prospective studies are needed to assess its risk and benefit for the patients.
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Objective To explore the efficacy of neoadjuvant chemoradiotherapy (CRT) followed by surgery for locally advanced esophageal squamous cell carcinoma (ESCC),and to investigate the correlation between a clinical complete response (cCR) and a pathologic complete response (pCR).Methods One hundred and fifty-eight patients with locally advanced thoracic ESCC from 2001 to 2013 were retrospectively analyzed.All patients received concurrent chemoradiotherapy followed by surgery.Platinumbased chemotherapy regimens were adopted in chemotherapy and a prescribed dose of 40 Gy in 20 fractions,5 fractions per week,was used in radiotherapy.The overall survival (OS) and disease-free survival (DFS) rates were calculated using the Kaplan-Meier method,and pairwise comparisons and univariate prognostic analyses were performed using the log-rank test.Multivariable prognostic analyses were performed using the Cox regression model.Results The pCR rate was 41.1％ in all patients.After the treatment with neoadjuvant CRT,32(72.7％) out of 44 patients with a cCR had a pCR,but only 33(28.9％) out of 114 patients with a non-cCR had a pCR (P =0.000).The sensitivity,specificity,positive predictive value,and negative predictive value of a cCR in predicting a pCR were 49.2％,87.1％,72.7％,and 71.1％,respectively.The 3-year sample size was 91.The 3-year OS and DFS rates in all patients were 53.9％ and 48.6％,respectively.Patients with a cCR had significantly higher 3-year OS and DFS rates than those with a non-cCR (P =0.012;P =0.026),while patients with a pCR had significantly higher 3-year OS and DFS rates than those with a non-pCR (P =0.000;P =0.000).The multivariate analyses demonstrated that the pathologic response after CRT and chemotherapy regimen were the influencing factors for OS.The most common grade ≥3 acute adverse reaction was leucopenia (34.2％).Conclusions With a high pCR rate and tolerable adverse reactions,neoadjuvant CRT followed by surgery is a safe and effective option for locally advanced ESCC.The cCR rate after CRT is closely correlated with the pCR and OS rates.
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Rectal cancer is a common type of malignant tumor, with increasing incidence over the previous years. Total mesorec-tal excision is the most important treatment for rectal cancer. Advanced rectal cancer presents high local recurrence rate and low sphinc-ter preservation rate. For locally advanced rectal cancer, neoadjuvant chemoradiotherapy is the optimal management strategy. In this re-gard, clinicians have focused on investigating the clinical effects of rectal cancer after neoadjuvant chemoradiotherapy. Prediction and evaluation of rectal cancer after neoadjuvant therapy can be used to determine further necessary treatments, effect on quality of life, and survival time of patients.
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OBJECTIVE: The aim of this study is to evaluate the efficacy of additional three cycles of platinum- based chemotherapy in epithelial ovarian cancer patients with clinical complete response (CR). METHODS: Patients with histologically confirmed epithelial ovarian cancer stage II-IV and showing clinical CR after primary surgery and six cycles of chemotherapy with platinum-based chemotherapy entered into the study. Three cycles of platinum/paclitaxel (cisplatin/paclitaxel or carboplatin/paclitaxel) or cyclophosphamide/cisplatin, cyclophosphamide/adriamycin/cisplatin were administered as a consolidation chemotherapy only in patients with an agreement to informed consent. RESULTS: A total of 96 patients entered into the study. According to informed consent, 47 patients were treated by consolidation chemotherapy and 49 patients were followed up without further treatment. The median follow-up period was 30.5 months in total patients. The mean number of chemotherapy courses administered on the consolidation arm was 2.7. The median actuarial disease-free survival for the patients without consolidation chemotherapy arm was 26.0 months and consolidation arm, 27.0 months. No difference was detected in disease-free survival (p=0.89). Median overall survival is not reached, but there was no significant difference between the two arms of the trial (p=0.76). WHO grade 3-4 toxicity criteria were emesis (4.1% vs. 2.1%), anemia and/or neutropenia (10.2% vs. 19.1%), and others (4.1% vs. 21.3%). CONCLUSION: Although sample size is small and not randomized, these results suggest that platinum- based consolidation chemotherapy do not provide a favorable outcome in terms of disease-free survival in patients with a clinical CR after debulking surgery and six cycles of same regimen.