Adjuvant Chemotherapy versus Chemotherapy plus Pelvic Irradiation for High-Risk Cervical Cancer Patients after Radical Hysterectomy and Pelvic Lymphadenectomy (RH-PLND): A Randomized Phase III Trial

5503 Background: The superiority of chemotherapy regimens employing a taxane plus a platinum agent over standard therapy with doxorubicin plus cisplatin (AP) was recently demonstrated for advanced or recurrent endometrial cancer. This multicenter phase III trial evaluated the clinical benefit of taxane plus platinum agent regimens as adjuvant chemotherapy compared with AP for endometrial cancer patients at high risk of recurrence after surgery. Methods: Endometrial cancer patients having a high risk of recurrence and postoperative residual disease < 2 cm were randomly assigned (1:1:1) with stratification by FIGO stage and histologic grade to receive 6 cycles of doxorubicin (60 mg/m2) plus cisplatin (50 mg/m2) on day 1 (AP), docetaxel (70 mg/m2) plus cisplatin (60 mg/m2) on day 1 (DP) or paclitaxel (180 mg/m2) plus carboplatin (AUC 6.0 mg/mL x minute) on day 1 (TC) every 3 weeks as adjuvant chemotherapy. The primary endpoint was progression-free survival (PFS). Secondary endpoints were overall survival (OS), adverse events, and tolerability. Results: From November 2006 to January 2011, 788 patients were enrolled from 118 institutions in Japan and were eligible for evaluation. The proportion of patients receiving 6 cycles was 80% for AP, 83% for DP, and 76% for TC, and tolerability of the regimens showed no significant difference. After a median follow-up period of 7.0 years, there was no statistical difference of PFS (P=0.1246) or OS (P=0.6734) among the 3 groups. The 5-year PFS rate was 74.9% for AP, 80.9% for DP, and 74.7% for TC, while the 5-year OS rates were 84.3%, 89.3%, and 88.4%, respectively. Conclusions: There was no significant difference of survival among patients receiving AP, DP, or TC as adjuvant chemotherapy for endometrial cancer. Since each regimen showed adequate tolerability, taxane plus platinum agent regimens may be a reasonable alternative to AP. Clinical trial information: UMIN000000522.

Download Full-text

Randomized phase III trial of radiotherapy or chemoradiotherapy with topotecan and cisplatin in intermediate-risk cervical cancer patients after radical hysterectomy

BMC Cancer ◽

10.1186/s12885-015-1355-1 ◽

2015 ◽

Vol 15 (1) ◽

Cited By ~ 8

Author(s):

Wenze Sun ◽

Tao Wang ◽

Fan Shi ◽

Jiquan Wang ◽

Juan Wang ◽

...

Keyword(s):

Cervical Cancer ◽

Cancer Patients ◽

Radical Hysterectomy ◽

Phase Iii ◽

Intermediate Risk ◽

Phase Iii Trial

Download Full-text

Concurrent paclitaxel/cisplatin chemoradiotherapy with or without consolidation chemotherapy in high-risk early-stage cervical cancer patients following radical hysterectomy: preliminary results of a phase III randomized study

Oncotarget ◽

10.18632/oncotarget.10450 ◽

2016 ◽

Vol 7 (43) ◽

pp. 70969-70978 ◽

Cited By ~ 2

Author(s):

Hongqin Zhao ◽

Lili Li ◽

Huafang Su ◽

Baochai Lin ◽

Xuebang Zhang ◽

...

Keyword(s):

Cervical Cancer ◽

High Risk ◽

Cancer Patients ◽

Radical Hysterectomy ◽

Early Stage ◽

Randomized Study ◽

Phase Iii ◽

Consolidation Chemotherapy ◽

Preliminary Results ◽

Early Stage Cervical Cancer

Download Full-text

Abstract P1-13-04: Optimal duration of adjuvant chemotherapy for high risk node negative breast cancer patients: 6-year results of the prospective randomized phase III trial PACS 05.

10.1158/0008-5472.sabcs12-p1-13-04 ◽

2012 ◽

Author(s):

P Kerbrat ◽

B Coudert ◽

B Asselain ◽

C Levy ◽

A Lortholary ◽

...

Keyword(s):

Breast Cancer ◽

High Risk ◽

Adjuvant Chemotherapy ◽

Cancer Patients ◽

Phase Iii ◽

Breast Cancer Patients ◽

Phase Iii Trial ◽

Node Negative ◽

Node Negative Breast Cancer ◽

Optimal Duration

Download Full-text

A randomized trial of adjuvant chemotherapy after radical hysterectomy in stage Ib-IIa cervical cancer patients with pelvic lymph node metastases☆

Gynecologic Oncology ◽

10.1016/0090-8258(92)90251-d ◽

1992 ◽

Vol 46 (2) ◽

pp. 176-181 ◽

Cited By ~ 67

Author(s):

M.H.N. Tattersall ◽

Corazon Ramirez ◽

Malcolm Coppleson

Keyword(s):

Cervical Cancer ◽

Lymph Node ◽

Adjuvant Chemotherapy ◽

Randomized Trial ◽

Cancer Patients ◽

Lymph Node Metastases ◽

Radical Hysterectomy ◽

Pelvic Lymph Node ◽

Stage Ib ◽

Node Metastases

Download Full-text

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

International Journal of Gynecological Cancer ◽

10.1136/ijgc-00009577-200505000-00014 ◽

2005 ◽

Vol 15 (3) ◽

pp. 498-502 ◽

Cited By ~ 1

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.

Download Full-text

Planned Safety Analysis of the ACTS-CC 02 Trial: A Randomized Phase III Trial of S-1 With Oxaliplatin Versus Tegafur and Uracil With Leucovorin as Adjuvant Chemotherapy for High-Risk Stage III Colon Cancer

Clinical Colorectal Cancer ◽

10.1016/j.clcc.2017.10.015 ◽

2018 ◽

Vol 17 (2) ◽

pp. e153-e161 ◽

Cited By ~ 2

Author(s):

Tetsuya Kusumoto ◽

Eiji Sunami ◽

Mitsuyoshi Ota ◽

Kazuhiro Yoshida ◽

Yoshiyuki Sakamoto ◽

...

Keyword(s):

Colon Cancer ◽

High Risk ◽

Adjuvant Chemotherapy ◽

Safety Analysis ◽

Phase Iii ◽

Stage Iii ◽

Phase Iii Trial ◽

Stage Iii Colon Cancer

Download Full-text

Delayed adjuvant radiotherapy in early-stage cervical cancer with intermediate-risk features has a detrimental effect on survival that cannot be corrected by adjuvant chemotherapy.

Journal of Clinical Oncology ◽

10.1200/jco.2020.38.15_suppl.6037 ◽

2020 ◽

Vol 38 (15_suppl) ◽

pp. 6037-6037

Author(s):

Joyson Kodiyan ◽

Adel Guirguis ◽

Hani Ashmalla

Keyword(s):

Cervical Cancer ◽

Adjuvant Chemotherapy ◽

Radical Hysterectomy ◽

Adjuvant Radiotherapy ◽

Early Stage ◽

Positive Margin ◽

Pelvic Lymphadenectomy ◽

Intermediate Risk ◽

Early Stage Disease ◽

Early Stage Cervical Cancer

6037 Background: GOG-0263 is currently investigating the role of adjuvant chemotherapy (CT) concurrently with radiotherapy (RT) in patients with early stage cervical cancer that underwent radical hysterectomy and pelvic lymphadenectomy harboring intermediate risk features. We used a retrospective database to investigate whether adjuvant chemotherapy significantly influenced overall survival (OS), and whether its effectiveness is influenced by delays in radiotherapy. Methods: All data was obtained from the NCDB (National Cancer Database) and initially contained 115,747 cases of cervical cancer diagnosed between 2004 and 2015. Analyzed patients had early stage disease, received radical hysterectomy with pathologic stage I to IIA, and had intermediate risk features including size greater than 4 cm or lymphovascular invasion. All patients received adjuvant RT with or without CT. Cases with positive margin or nodes, with parametrial extension, or metastasis were excluded. Cases were weighted by inverse probability of treatment (CT) using clinical and socioeconomic variables, and analyzed for OS using multivariate models. Predictors of receiving CT were determined using multivariate logistic regression. Results: The final cohort was 557 patients with median follow-up of 43 months (range, 1.54-143.7). Median survival without CT (n = 244) versus with CT (n = 313) was 42.2 versus 43.9 months (HR 0.81, 95%CI 0.661-0.995, p = 0.045). Median time from diagnosis to RT was 91 days (range, 21-691), and predicted for inferior OS (p = 0.007). No significant interaction existed between RT delay and receipt of CT (p = 0.997). Cases with squamous histology were less likely to receive CT than adenocarcinoma histology (OR 0.345, 95%CI 0.159-0.725, p = 0.006). Conclusions: Poor survival outcomes are observed in patients with early stage cervical cancer harboring intermediate risk features when adjuvant radiotherapy is delayed. This outcome was not corrected by addition of chemotherapy.

Download Full-text