A randomized phase III trial of adjuvant chemotherapy versus concurrent chemoradiotherapy (CCRT) for postoperative cervical cancer: Japanese Gynecologic Oncology Group study (JGOG1082).

2020 ◽  
Vol 38 (15_suppl) ◽  
pp. TPS6094-TPS6094
Author(s):  
Akiko Furusawa ◽  
Munetaka Takekuma ◽  
Tomoka Usami ◽  
Eiji Kondo ◽  
Shin Nishio ◽  
...  
Keyword(s):  
Cervical Cancer ◽  
High Risk ◽  
Adjuvant Chemotherapy ◽  
Radical Hysterectomy ◽  
Concurrent Chemoradiotherapy ◽  
Disease Free Survival ◽  
Free Survival ◽  
Stage Ib ◽  
Pelvic Lymph Node Metastasis ◽  
Disease Free

TPS6094 Background: Cervical cancer is one of the common gynecologic cancer and the incidence of invasive cervical cancer has increased over the past few decades, particularly in younger women. The standard treatment for stage IB to IIB cervical cancer is a radical hysterectomy. In Japan, more than 80% of institutions, radical hysterectomy is chosen as the primary treatment for patients with stage IB1 and IIA1 cervical cancer. Patients with high-risk factors would be recommend adjuvant concurrent chemoradiotherapy (CCRT). However, adjuvant CCRT might not reduce distant metastasis and might cause of severe gastrointestinal and urinal toxicity. To avoid those adverse events of adjuvant CCRT, many Japanese gynecologic oncologists perform chemotherapy as adjuvant therapy. In the first multi-institutional phase II trial conducted in stage IB-IIA cervical cancer with pelvic lymph node metastasis (JGOG1067), we found a 5-years disease free-survival rate of 86.5%, suggesting the adjuvant chemotherapy had promising efficacy and would be feasible for a long time. No prospective study reported that adjuvant chemotherapy would improve overall survival in patients with the high-risk cervical cancer. Methods: High risk stage IB-IIB cervical cancer patients who underwent radical hysterectomy are eligible for the study. Patients with high risk are defined as those with pelvic lymph-node metastasis and/or parametrial invasion. Patents with SCC, adenocarcinoma, adenosquamous cell carcinoma are eligible for the study. After providing informed consent, patients are randomized on a 1:1 basis to receive CCRT or chemotherapy. Randomization is stratified by the faculty, FIGO stage, and pathological subtype (SCC or non-SCC). Treatment have to be started within 6 weeks after surgery. CCRT group is given whole pelvis irradiation 50.4Gy and cisplatin (40mg/m2/week). Chemotherapy group is given paclitaxel (175mg/m2) plus cisplatin (50mg/m2) or paclitaxel (175mg/m2) plus carboplatin(AUC of 6). The primary endpoint is overall survival (OS). Secondary endpoints are disease free survival (DFS), adverse events and QOL. This study began in November 2019 and a total of 290 patients will be accrued within 5 years. The study is coordinated by of the JGOG cervical cancer committee. Clinical trial information: 041190042.

scholarly journals Oncological outcomes of laparoscopic radical hysterectomy versus radical abdominal hysterectomy in patients with early-stage cervical cancer: a multicenter analysis

2021 ◽  
pp. ijgc-2020-002086
Author(s):  
Juliana Rodriguez ◽  
Jose Alejandro Rauh-Hain ◽  
James Saenz ◽  
David Ortiz Isla ◽  
Gabriel Jaime Rendon Pereira ◽  
...  
Keyword(s):  
Cervical Cancer ◽  
Radical Hysterectomy ◽  
Early Stage ◽  
Disease Free Survival ◽  
Free Survival ◽  
Laparoscopic Radical Hysterectomy ◽  
Oncological Outcomes ◽  
Early Stage Cervical Cancer ◽  
Laparotomy Group ◽  
Disease Free

IntroductionRecent evidence has shown adverse oncological outcomes when minimally invasive surgery is used in early-stage cervical cancer. The objective of this study was to compare disease-free survival in patients that had undergone radical hysterectomy and pelvic lymphadenectomy, either by laparoscopy or laparotomy.MethodsWe performed a multicenter, retrospective cohort study of patients with cervical cancer stage IA1 with lymph-vascular invasion, IA2, and IB1 (FIGO 2009 classification), between January 1, 2006 to December 31, 2017, at seven cancer centers from six countries. We included squamous, adenocarcinoma, and adenosquamous histologies. We used an inverse probability of treatment weighting based on propensity score to construct a weighted cohort of women, including predictor variables selected a priori with the possibility of confounding the relationship between the surgical approach and survival. We estimated the HR for all-cause mortality after radical hysterectomy with weighted Cox proportional hazard models.ResultsA total of 1379 patients were included in the final analysis, with 681 (49.4%) operated by laparoscopy and 698 (50.6%) by laparotomy. There were no differences regarding the surgical approach in the rates of positive vaginal margins, deep stromal invasion, and lymphovascular space invasion. Median follow-up was 52.1 months (range, 0.8–201.2) in the laparoscopic group and 52.6 months (range, 0.4–166.6) in the laparotomy group. Women who underwent laparoscopic radical hysterectomy had a lower rate of disease-free survival compared with the laparotomy group (4-year rate, 88.7% vs 93.0%; HR for recurrence or death from cervical cancer 1.64; 95% CI 1.09–2.46; P=0.02). In sensitivity analyzes, after adjustment for adjuvant treatment, radical hysterectomy by laparoscopy compared with laparotomy was associated with increased hazards of recurrence or death from cervical cancer (HR 1.7; 95% CI 1.13 to 2.57; P=0.01) and death for any cause (HR 2.14; 95% CI 1.05–4.37; P=0.03).ConclusionIn this retrospective multicenter study, laparoscopy was associated with worse disease-free survival, compared to laparotomy.

Radical hysterectomy in early cervical cancer in Europe: characteristics, outcomes and evaluation of ESGO quality indicators

2021 ◽  
pp. ijgc-2021-002587
Author(s):  
Felix Boria ◽  
Luis Chiva ◽  
Vanna Zanagnolo ◽  
Denis Querleu ◽  
Nerea Martin-Calvo ◽  
...  
Keyword(s):  
Cervical Cancer ◽  
Overall Survival ◽  
Quality Indicators ◽  
Radical Hysterectomy ◽  
Disease Free Survival ◽  
Free Survival ◽  
Operative Complications ◽  
Early Cervical Cancer ◽  
Disease Free

IntroductionComprehensive updated information on cervical cancer surgical treatment in Europe is scarce.ObjectiveTo evaluate baseline characteristics of women with early cervical cancer and to analyze the outcomes of the ESGO quality indicators after radical hysterectomy in the SUCCOR database.MethodsThe SUCCOR database consisted of 1272 patients who underwent radical hysterectomy for stage IB1 cervical cancer (FIGO 2009) between January 2013 and December 2014. After exclusion criteria, the final sample included 1156 patients. This study first described the clinical, surgical, pathological, and follow-up variables of this population and then analyzed the outcomes (disease-free survival and overall survival) after radical hysterectomy. Surgical-related ESGO quality indicators were assessed and the accomplishment of the stated recommendations was verified.ResultsThe mean age of the patients was 47.1 years (SD 10.8), with a mean body mass index of 25.4 kg/m2 (SD 4.9). A total of 423 (36.6%) patients had a previous cone biopsy. Tumor size (clinical examination) <2 cm was observed in 667 (57.7%) patients. The most frequent histology type was squamous carcinoma (794 (68.7%) patients), and positive lymph nodes were found in 143 (12.4%) patients. A total of 633 (54.8%) patients were operated by open abdominal surgery. Intra-operative complications occurred in 108 (9.3%) patients, and post-operative complications during the first month occurred in 249 (21.5%) patients, with bladder dysfunction as the most frequent event (119 (10.3%) patients). Clavien-Dindo grade III or higher complication occurred in 56 (4.8%) patients. A total of 510 (44.1%) patients received adjuvant therapy. After a median follow-up of 58 months (range 0–84), the 5-year disease-free survival was 88.3%, and the overall survival was 94.9%. In our population, 10 of the 11 surgical-related quality indicators currently recommended by ESGO were fully fulfilled 5 years before its implementation.ConclusionsIn this European cohort, the rate of adjuvant therapy after radical hysterectomy is higher than for most similar patients reported in the literature. The majority of centers were already following the European recommendations even 5 years prior to the ESGO quality indicator implementations.

scholarly journals Adjuvant Gemcitabine-Oxaliplatin (GeMOX) after Curative Surgery in High-risk Patients with Cholangiocarcinoma

2009 ◽  
Vol 3 ◽  
pp. CMO.S3360
Author(s):  
Bernard Paule ◽  
Paola Andreani ◽  
Marie-Pierre Bralet ◽  
Catherine Guettier ◽  
René Adam ◽  
...  
Keyword(s):  
Survival Rate ◽  
High Risk ◽  
Adjuvant Chemotherapy ◽  
Disease Free Survival ◽  
Curative Surgery ◽  
Free Survival ◽  
High Risk Factors ◽  
Risk Patients ◽  
Disease Free Survival Rate ◽  
Disease Free

Background There is no standard adjuvant chemotherapy to prevent recurrent cholangiocarcinoma (CCA), a rare cancer with poor prognosis. We assessed the efficacy and safety of GEMOX on intrahepatic and hilar CCA with high-risk factors after curative surgery. Patients and Methods Twenty two patients (mean age: 57 years old) with CCA received 6 cycles of GEMOX: gemcitabine 1,000 mg/m2 on day 1 and oxaliplatin 85 mg/m2 on day 2, q3w after a curative surgery. Results All patients completed 6 cycles of GEMOX. EGFR membranous expression was present in 20 CCA. The 5-year survival rate was 56% (CI 95%: 25.7–85.4); 2-year disease free survival rate was 28% (CI 95%: 3.4–52.6). Median time to progression was 15 months. The rate of recurrence after surgery and chemotherapy was 63% (14/22). Two patients died of disease progression. Twelve patients received cetuximab/GEMOX at the time of relapse. Six died after 12 months (9–48 months), three are still alive suggesting a clinical applicability of EGFR inhibitors in CCA. Conclusion Adjuvant chemotherapy with GEMOX alone seems ineffective in intrahepatic and hilar CCA with a high risk of relapse. Additional studies including targeted therapies to circumvent such poor chemosensitivity are needed.

Outcomes of abandoned radical hysterectomy in patients with stages IB–IIA cervical cancer found to have positive nodes during the operation

2005 ◽  
Vol 15 (3) ◽  
pp. 498-502 ◽  
Author(s):  
P. Suprasert ◽  
J. Srisomboon ◽  
K. Charoenkwan ◽  
S. Siriaungul ◽  
S. Khunamornpong ◽  
...  
Keyword(s):  
Cervical Cancer ◽  
Cancer Patients ◽  
Radical Hysterectomy ◽  
Disease Free Survival ◽  
Pelvic Lymphadenectomy ◽  
Adjuvant Radiation ◽  
Free Survival ◽  
Number Of Patients ◽  
Extended Field ◽  
Disease Free

The objective of this study was to evaluate the outcomes of stages IB–IIA cervical cancer patients whose radical hysterectomy (RH) was abandoned for positive pelvic nodes detected during the operation compared with those found to have positive nodes after the operation. Among 242 patients with planned RH and pelvic lymphadenectomy (RHPL) for stages IB–IIA cervical cancer, 23 (9.5%) had grossly positive nodes. RH was abandoned, and complete pelvic lymphadenectomy was performed. Of these 23 patients, 22 received adjuvant chemoradiation, and the remaining 1 received adjuvant radiation. Four patients with positive para-aortic nodes were additionally treated with extended-field irradiation. When compared with 35 patients whose positive nodes were detected after the operation, there were significant differences regarding number of positive nodes and number of patients receiving extended-field irradiation. Complications in both groups were not significantly different, but the 2-year disease-free survival was significantly lower in the abandoned RH group compared with that of the RHPL group (58.5% versus 93.5%, P = 0.01). In conclusion, the survival of stages IB–IIA cervical cancer patients whose RH was abandoned for grossly positive pelvic nodes was significantly worse than that of patients whose node metastasis was identified after the operation. This is because the abandoned RH group had worse prognostic factors.

Adjuvant cyclophosphamide, doxorubicin, and cisplatin chemotherapy for bladder cancer: an update.

1988 ◽  
Vol 6 (10) ◽  
pp. 1590-1596 ◽  
Author(s):  
C J Logothetis ◽  
D E Johnson ◽  
C Chong ◽  
F H Dexeus ◽  
A Sella ◽  
...  
Keyword(s):  
High Risk ◽  
Adjuvant Chemotherapy ◽  
Primary Tumor ◽  
Disease Free Survival ◽  
Nodal Metastases ◽  
Pathological Findings ◽  
Free Survival ◽  
Prognostic Features ◽  
Disease Free

Seventy-one patients received adjuvant Cytoxan (cyclophosphamide; Bristol-Myers Co, Evansville, IN), Adriamycin (doxorubicin; Adria Laboratories, Columbus, OH), and cisplatin (CISCA) chemotherapy between March 1981 and March 1986. Patients received adjuvant CISCA chemotherapy if they had pathological findings that were thought to predict for high likelihood of relapse. These included the presence of resected nodal metastases, extravesicular involvement of tumor, lymphatic/vascular permeation of the primary tumor, or pelvic visceral invasion. Sixty-two patients at a similar high risk for recurrence did not receive adjuvant CISCA chemotherapy because they refused, had medical contraindications to therapy, or were not referred for chemotherapy. Two-hundred six patients had a cystectomy performed during the same study period but had none of the poor prognostic features suggesting a high risk for relapse. Sixty-two percent of the patients receiving adjuvant chemotherapy are alive and disease-free for a mean follow-up of 118 weeks (range, 28 to 310 weeks). A survival advantage exists for the adjuvant-treated patients when compared with those with unfavorable pathological findings who did not receive adjuvant chemotherapy (70% v 37%) (P = .00012): no difference exists in long-term disease-free survival for those with favorable pathological findings (long-term disease-free survival 76%) v those who received adjuvant chemotherapy (70%) (P = .33). Adjuvant CISCA chemotherapy prolongs the disease-free survival of some patients following a cystectomy. Patients who benefitted from adjuvant CISCA chemotherapy included those with resected nodal metastases, extra-vesicular involvement of tumor, and direct invasion of the pelvic viscera. Patients not benefitting from adjuvant CISCA chemotherapy in this analysis included those with lymphatic/vascular invasion in their primary tumor as the sole manifestation of high risk for relapse.

Efficacy and tolerability of adjuvant therapy in ≥70-year-old patients with T3N0M0 colorectal cancer: An observational study

2019 ◽  
Vol 26 (3) ◽  
pp. 619-631
Author(s):  
Abdullah Sakin ◽  
Nurgul Yasar ◽  
Suleyman Sahin ◽  
Serdar Arici ◽  
Saban Secmeler ◽  
...  
Keyword(s):  
Colorectal Cancer ◽  
Overall Survival ◽  
Lymph Node ◽  
High Risk ◽  
Adjuvant Chemotherapy ◽  
Risk Group ◽  
Disease Free Survival ◽  
Old Patients ◽  
Free Survival ◽  
Disease Free

Background This study aimed to retrospectively investigate the efficacy and tolerability of adjuvant chemotherapy in ≥70-year-old patients with stage IIA (T3N0M0) colorectal cancer. Methods Lymphovascular invasion, perineural invasion, margin positivity, dissected lymph node count of <12, and presence of perforation/obstruction were accepted as risk factors. Those patients with at least one risk factor were regarded as having high risk. Results The study included 168 patients, among which 95 (56.5%) were male and 73 (43.5%) were female. The median age of patients was 73 years (range: 70–94). One hundred one (60.1%) patients were identified to have high risk. Eighty-one (87%) patients received 5-flourouracil+leucovorin and 12 (13%) patients received capecitabine regimens as adjuvant chemotherapy. The patients receiving capecitabine regimen had significantly higher rates of dose reduction at initiation and during the treatment. Among low-risk group, there was no statistically significant difference between patients with and without adjuvant chemotherapy in terms of disease-free survival or overall survival (p = 0.528 and p = 0.217, respectively). In high-risk group, patients receiving adjuvant chemotherapy significantly differed from those not receiving adjuvant chemotherapy in terms of median disease-free survival and overall survival (p = 0.009 and p < 0.001, respectively). While the grade, lymph node status, and adjuvant chemotherapy were identified as the most significant independent factors for disease-free survival, the most significant factors for overall survival were the age, Eastern Cooperative Oncology Group performance status, adjuvant chemotherapy, and recurrence. Conclusion The findings of our study showed improved disease-free survival and overall survival in high-risk ≥70-year-old patients who received adjuvant chemotherapy due to T3N0M0 colorectal cancer. We believe that 5-flourouracil+leucovorin or capecitabine regimens should be recommended for these older high-risk patients who could receive adjuvant chemotherapy regardless of age.

Minimally invasive radical hysterectomy: an analysis of oncologic outcomes from Hospital Italiano (Argentina)

2019 ◽  
Vol 29 (5) ◽  
pp. 863-868 ◽  
Author(s):  
Diego Odetto ◽  
Maria Celeste Puga ◽  
Jose Saadi ◽  
Florencia Noll ◽  
Myriam Perrotta
Keyword(s):  
Cervical Cancer ◽  
Recurrence Rate ◽  
Radical Hysterectomy ◽  
Adenosquamous Carcinoma ◽  
Disease Free Survival ◽  
Laparoscopic Approach ◽  
Free Survival ◽  
Laparoscopic Radical Hysterectomy ◽  
Disease Free

BackgroundThe Laparoscopic Approach to Cervical Cancer (LACC) trial demonstrated a higher rate of disease recurrence and worse disease-free survival in patients who underwent minimally invasive radical hysterectomy.ObjectivesTo evaluate surgical and oncological outcome of laparoscopic radical hysterectomy performed at Hospital Italiano in Buenos Aires, Argentina.MethodsThis retrospective study included all patients with cervical cancer, 2009 FIGO stage IA1, with lymphovascular invasion to IB1 (<4 cm) who underwent a laparoscopic radical hysterectomy between June 2010 and June 2015. Patients were eligible if they had squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma, and no lymph node involvement by imaging. Patients must have undergone a type C1 radical hysterectomy. Only patients who were treated by a laparoscopic approach were included. Patients were excluded if histopathology showed a component of neuroendocrine carcinoma before or after surgery; if they had synchronous primary tumors, history of abdominal or pelvic radiotherapy, or were operated on at an outside institution; and if they had only surgery and no follow-up in our institution. Relapse rate and disease-free survival were evaluated using the Kaplan-Meier method.ResultsA total of 108 patients were evaluated. The median age was 41 years (range 27–70). Distribution of histologic sub-types was squamous carcinoma in 77 patients (71%), adenocarcinoma in 27 patients (25%), and adenosquamous carcinoma in four patients (4%). Ninety-nine patients (92%) had stage IB1 tumors and 58 (54%) patients had tumors ≤2 cm. The median surgical time was 240 min (range 190–290), the median estimated blood loss was 140 mL (range 50–500) and the transfusion rate was 3.7%. The median length of hospital stay was 2 days (range 1–11). The median follow-up time was 39 months (range 11–83). The global recurrence rate after laparoscopic radical hysterectomy was 15% (16/108). According to tumor size, the recurrence rate was 12% in patients with tumors ≤2 cm (7/58) and 18% in patients with tumors >2 cm (9/50) (OR=0.76; 95% CI 0.26 to 2.22; p=0.62) The 3- and 5-year relapse rate was 17% (95% CI 11% to 27%). The 3- and 5-year disease-free survival was 81% (95% CI 71% to 88%) and 70% (95% CI 43% to 86%), respectively. Overall survival at 3 years was 87% (95% CI 76% to 93%).ConclusionThe recurrence rate after laparoscopic radical hysterectomy was 15%, and in tumors ≤2 cm it was 12%. The 3-year disease-free survival was 81%. Given these results our hospital has changed the approach to open radical hysterectomy.

Pelvic Irradiation With Concurrent Chemotherapy Versus Pelvic and Para-Aortic Irradiation for High-Risk Cervical Cancer: An Update of Radiation Therapy Oncology Group Trial (RTOG) 90-01

2004 ◽  
Vol 22 (5) ◽  
pp. 872-880 ◽  
Author(s):  
Patricia J. Eifel ◽  
Kathryn Winter ◽  
Mitchell Morris ◽  
Charles Levenback ◽  
Perry W. Grigsby ◽  
...  
Keyword(s):  
Cervical Cancer ◽  
Overall Survival ◽  
Survival Rate ◽  
Locally Advanced ◽  
Disease Free Survival ◽  
Disease Stage ◽  
Tumor Diameter ◽  
Free Survival ◽  
Stage Ib ◽  
Disease Free

Purpose To report mature results of a randomized trial that compared extended-field radiotherapy (EFRT) versus pelvic radiotherapy with concomitant fluorouracil and cisplatin (CTRT) in women with locoregionally advanced carcinomas of the uterine cervix. Patients and Methods Four hundred three women with cervical cancer were randomly assigned to receive either EFRT or CTRT. Patients were eligible if they had stage IIB to IVA disease, stage IB to IIA disease with a tumor diameter ≥ 5 cm, or positive pelvic lymph nodes. Patients were stratified by stage and by method of lymph node evaluation. Results The median follow-up time for 228 surviving patients was 6.6 years. The overall survival rate for patients treated with CTRT was significantly greater than that for patients treated with EFRT (67% v 41% at 8 years; P < .0001). There was an overall reduction in the risk of disease recurrence of 51% (95% CI, 36% to 66%) for patients who received CTRT. Patients with stage IB to IIB disease who received CTRT had better overall and disease-free survival than those treated with EFRT (P < .0001); 116 patients with stage III to IVA disease had better disease-free survival (P = .05) and a trend toward better overall survival (P = .07) if they were randomly assigned to CTRT. The rate of serious late complications of treatment was similar for the two treatment arms. Conclusion Mature analysis confirms that the addition of fluorouracil and cisplatin to radiotherapy significantly improved the survival rate of women with locally advanced cervical cancer without increasing the rate of late treatment-related side effects.

scholarly journals Early Postoperative Paclitaxel Followed by Concurrent Paclitaxel and Cisplatin With Radiation Therapy for Patients With Resected High-Risk Head and Neck Squamous Cell Carcinoma: Report of the Phase II Trial RTOG 0024

2009 ◽  
Vol 27 (28) ◽  
pp. 4727-4732 ◽  
Author(s):  
David I. Rosenthal ◽  
Jonathan Harris ◽  
Arlene A. Forastiere ◽  
Randal S. Weber ◽  
John A. Ridge ◽  
...  
Keyword(s):  
Radiation Therapy ◽  
High Risk ◽  
Head And Neck ◽  
Squamous Cell ◽  
Concurrent Chemoradiotherapy ◽  
Disease Free Survival ◽  
Locoregional Control ◽  
Free Survival ◽  
Positive Margins ◽  
Disease Free

Purpose We sought to improve outcomes for patients with high-risk head and neck squamous cell cancer (HNSCC) after surgical resection by testing the feasibility and safety of early postoperative chemotherapy followed by concurrent chemoradiotherapy. Patients and Methods Eligible patients had resected, stages III to IV HNSCC with positive margins, extracapsular nodal extension, or multiple positive nodes. Paclitaxel (80 mg/m2) was given once weekly during postoperative weeks 2, 3, and 4 and was given before radiation therapy (RT). Paclitaxel (30 mg/m2) and cisplatin (20 mg/m2) were given once weekly during the last 3 weeks of RT (60 Gy over 6 weeks, beginning 4 to 5 weeks after surgery). The primary end points were treatment safety and tolerability compared with concurrent cisplatin (100 mg/m2 every 3 weeks) and RT, as tested in Radiation Therapy Oncology Group trial RTOG 9501. Results The median follow-up time for the 70 patients enrolled was 3.3 years (range, 0.6 to 4.4 years) for surviving patients. Tolerability of all treatment components was comparable to that of RTOG 9501 treatment, which is the current standard of care (compliance rate, 75%; 95% CI, 63% to 85%). One patient died, and seven patients experienced grade 4 nonhematologic toxicities. Rates of locoregional control, disease-free survival, and overall survival exceeded those of RTOG 9501 after adjustment for important prognostic variables (ie, positive margins, extracapsular extension, primary site, and performance status). Conclusion Chemotherapy soon after surgery followed by concurrent chemoradiotherapy therapy was feasible; tolerance was in line with standard postoperative chemoradiotherapy; and this regimen led to excellent rates of locoregional control and disease-free survival.

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