Phase II trial of intraperitoneal paclitaxel in carcinoma of the ovary, tube, and peritoneum: a Gynecologic Oncology Group Study.

1998 ◽  
Vol 16 (8) ◽  
pp. 2620-2624 ◽  
Author(s):  
M Markman ◽  
M F Brady ◽  
N M Spirtos ◽  
P Hanjani ◽  
S C Rubin
Keyword(s):  
Residual Disease ◽  
Treatment Plan ◽  
Gynecologic Oncology ◽  
Complete Response ◽  
Phase Iii ◽  
Maximum Diameter ◽  
Gynecologic Oncology Group ◽  
Eligibility Criteria ◽  
Grade 3 ◽  
The Impact

PURPOSE To determine the response rate of intraperitoneal (i.p.) paclitaxel in patients with small-volume residual carcinomas of the ovary, fallopian tube, or peritoneum. PATIENTS AND METHODS Eligibility criteria included patients with one of the cancers noted above, with the largest residual disease 0.5 cm or less in maximum diameter at the end of second-look surgery, and prior treatment with systemic paclitaxel was permitted. The treatment plan was paclitaxel 60 mg/m2 i.p. weekly for 16 weeks, followed by surgical evaluation in patients without evidence of disease progression. RESULTS Of 80 patients entered onto the study, 76 were eligible, of whom 86% were considered to be potentially cisplatin-sensitive. Although five patients (7%) did not complete the first course of therapy because of catheter leakage or blockade, 53 patients (70%) received all 16 planned courses. Only 14 patients (18%) received fewer than 11 courses. Treatment was well tolerated, which included only moderate abdominal pain (grade 2, 12 patients; grade 3, one patient) and minimal neutropenia (grade 2, three patients; grade 3, one patient). Of 28 assessable patients with microscopic disease at the start of i.p. therapy, 17 patients (61%) achieved a surgically defined complete response (CR). Only one of 31 patients (3%) with any macroscopic disease achieved a CR. Of the eligible patients, 18 of 76 (24%) achieved a CR. CONCLUSION Salvage i.p. paclitaxel is tolerable and active in patients with microscopic residual disease. The impact of this treatment strategy on survival remains to be assessed in a phase III trial.

Phase III trial of bevacizumab (BEV) in the primary treatment of advanced epithelial ovarian cancer (EOC), primary peritoneal cancer (PPC), or fallopian tube cancer (FTC): A Gynecologic Oncology Group study.

2010 ◽  
Vol 28 (18_suppl) ◽  
pp. LBA1-LBA1 ◽  
Author(s):  
R. A. Burger ◽  
M. F. Brady ◽  
M. A. Bookman ◽  
J. L. Walker ◽  
H. D. Homesley ◽  
...  
Keyword(s):  
Residual Disease ◽  
Gynecologic Oncology ◽  
Single Agent ◽  
Stage Iv ◽  
Phase Iii ◽  
Stage Iii ◽  
Gynecologic Oncology Group ◽  
Fallopian Tube Cancer ◽  
Phase Iii Trial ◽  
Grade 3

LBA1 Background: BEV, a humanized anti-VEGF monoclonal antibody, has demonstrated single-agent activity in patients with recurrent EOC, or PPC. The therapeutic impact of concurrent ± maintenance BEV with standard chemotherapy (CT) was evaluated in an international, double-blind, placebo-controlled phase III trial. Methods: Eligible patients had newly diagnosed, previously untreated EOC, PPC or FTC following abdominal surgery for staging and maximal effort at tumor debulking; stage III (macroscopic residual disease) or stage IV disease. The randomly allocated regimens were (1) CT (IV paclitaxel 175 mg/m2 + carboplatin AUC 6 cycles 1-6) + placebo cycles (C)2-22 (R1) (2) CT + concurrent BEV (15 mg/kg) C2-6 + placebo C7-22 (R2) (3) CT + concurrent BEV C2-6 + maintenance BEV C7-22 (R3) Infusions were administered d1 of a 21d cycle. The primary endpoint is progression-free survival (PFS) (radiographic, CA125, clinical criteria or death); secondary endpoints include overall survival, safety, and QoL. Results: 1,873 patients, median age 60, were enrolled from 9/05 - 6/09. Stage III optimally debulked (34%), stage III sub-optimally debulked (40%), and stage IV (26%) patients were similarly distributed in each treatment group. Grade 3 - 4 hypertension was reported in 1.6% (R1), 5.4% (R2), and 10.0% (R3). Grade ≥ 3 GI perforation, hemorrhage or fistula occurred in 0.8% (R1), 2.6% (R2) and 2.3% (R3). Relative to R1, the hazard of first progression or death for R2 was 0.908 (95% CI: 0.795 – 1.04, p=0.16) and for R3 was 0.717 (95% CI: 0.625 – 0.824, p<0.0001). Conclusions: This study demonstrates that front-line treatment of EOC, PPC, and FTC patients with CT plus concurrent and maintenance BEV prolongs PFS. This is the first anti-angiogenic agent to demonstrate benefit in this population. [Table: see text]

Granulocyte-Colony Stimulating Factor Use in Young Fit CLL Patients Receiving Fludarabine-Cyclophosphamide-Rituximab Frontline: Impact on Outcomes, Relative Dose Intensity and Toxicities

Blood ◽  
2011 ◽  
Vol 118 (21) ◽  
pp. 1798-1798
Author(s):  
Emmanuelle Bouvet ◽  
Lucie Oberic ◽  
Christian Recher ◽  
Françoise Huguet ◽  
Xavier Carles ◽  
...  
Keyword(s):  
Creatinine Clearance ◽  
Residual Disease ◽  
Dose Intensity ◽  
Phase Iii ◽  
Relative Dose Intensity ◽  
Color Flow ◽  
Group 2 ◽  
Grade 3 ◽  
The Impact ◽  
Group 1

Abstract Abstract 1798 INTRODUCTION: fludarabine-cyclophosphamide-rituximab (FCR) is the standard upfront immunochemotherapy for young fit CLL patients. The clinical benefit of growth factors support is yet unclear, despite recently published possible impact on outcomes in a series of 32 patients [Grüber M, 2011]. The use of G-CSF is not recommended in the CLL8 trial, outside febrile neutropenia, but often applied outside clinical trials to prevent toxicities and achieve good relative dose-intensity (RDI). We retrospectively assessed, in an Hematology healthcare network, the impact of G-CSF on survivals (PFS, TTNT, OS), outcomes (RDI, minimal residual disease (MRD), overall response rates (CR/CRi), and toxicities (grade 3–4 neutropenia, fever, hospitalizations). PATIENTS AND METHODS: among 101 patients treated with FCR frontline, three groups of patients are considered: group 1 (no G-CSF), group 2 (primary prophylaxis with pegfilgrastim after each course of FCR), and group 3 (patients of group 1 initially, but who were treated with G-CSF due to at least one episode of grade 4 neutropenia (at the discretion of the physician)). Respectively, toxicities have been assessed in 24/28/13 patients, and outcomes in 45/23/23 patients. Pretreatment characteristics were well balanced between G-CSF-naïve and -treated patients (IgVH, Binet stage, del11q). No del17p patient was included in this series. Planned RDI for F and C were calculated before 1st cycle of FCR according to age (-20% if >65y), and creatinine clearance (-25% if <60ml/mn). Average RDI (ARDI) actually prescribed to patients were assessed at the last cycle, in mg/m2/week (6xFCR=24 wks) to include dose delays in the calculation of RDI. RESULTS: median age in the cohort of 101 FCR treated pts was 60y (21–83y), 68% were males. 20% had >65y, 13% had creatinine clearance <60ml/mn, CIRS-G comorbidity scores were: 0 (25.5%), 1 (26.5%), 2 (19%), 3 (10%), 4 (8%), 5 (5%), 6 (2%), ≥7 (4%). Planned RDI was ≤75% standard FCR doses (due to age, CrCL, or physician's choice) in 12% of cases, and ARDI was further decreased ≥20% of initial planned RDI in 25% of patients. Peripheral blood 4-color flow MRD wad undetectable in 49% of patients. Impact of G-CSF use on outcomes: results are summarized in Table 1. The use of G-CSF on curative intent for grade 4 neutropenia induced an increase in rates of CRi and prolonged neutropenia at the end of therapy. When used at the time of neutropenia (d15-d21 after FCR cycle), stimulation with G-CSF may be deleterious due to the prescription of the next FCR at d28. Median PFS, TTNT, OS were not significantly improved by the use of G-CSF (prophylactic or curative). G-CSF did not impact on MRD levels neither. MRD eradication was the strongest parameter linked to PFS/TTNT. Impact of G-CSF use on toxicities and RDI: results are summarized in Table 2. The use of prophylactic G-CSF (group 2) significantly reduced the rate of neutropenia grade 3–4, and tended to decrease the need for antibiotics given for fever. A dose modification (>10%) was observed in 26% vs 33.3% in patients receiving prophylactic G-CSF or not, respectively. A planned RDI <75% standard FCR doses was linked to reduced PFS and TTNT, but not OS. Prophylactic G-CSF did not prevent a decrease >20% of planned RDI at the end of therapy. CONCLUSIONS: Our data suggest that prophylactic G-CSF use after FCR decreases toxicities but does not impact on outcomes. We plan to study G-CSF impact on FCR results in an older, less fit population (FORTIS phase III trial). Disclosures: Ysebaert: Roche: Membership on an entity's Board of Directors or advisory committees, Research Funding.

Phase III randomized trial of definitive chemoradiotherapy (CRT) with FOLFOX or cisplatin and fluorouracil in esophageal cancer (EC): Final results of the PRODIGE 5/ACCORD 17 trial.

2012 ◽  
Vol 30 (18_suppl) ◽  
pp. LBA4003-LBA4003 ◽  
Author(s):  
Thierry Conroy ◽  
Marie-Pierre Galais ◽  
Jean Luc Raoul ◽  
Olivier Bouche ◽  
Sophie Gourgou-Bourgade ◽  
...  
Keyword(s):  
Squamous Cell ◽  
Treatment Options ◽  
Complete Response ◽  
Phase Iii ◽  
Eligibility Criteria ◽  
Randomized Phase Ii ◽  
Secondary Endpoints ◽  
Grade 3 ◽  
Ecog Ps

LBA4003 Background: CRT is one of the best treatment options for localized EC. As new combinations are required to improve safety and survival, we launched a randomized phase II study to assess the complete response (CR) rate of CRT with FOLFOX versus 5FU/cisplatin in 97 pts with localized EC (Conroy 2010). The trial having met its objectives, it has been pursued as a phase III trial. Stratified randomization was performed centrally in a 1:1 ratio according to histological type, pretreatment weight loss in the prior 6 months (<10% vs ≥10%), ECOG PS (0 vs 1 vs 2), and center. Methods: Pts with technically unresectable cancer or those with surgical contraindications or who refused to undergo surgery were eligible. Eligibility criteria also included age >18 years (y), PS ≤ 2, previously untreated adenocarcinoma or squamous cell EC (any T, N0 or N1, M0 or M1a). The radiation dose was 50 Gy (2Gy/fr) 5 d/wk for 5 wks in both arms. In Arm A, pts received 6 bimonthly cycles (cy): oxaliplatin 85 mg/m2 d1 and leucovorin 200 mg/m2 followed by 5-FU 400 mg/m2 bolus d1 then 1,600 mg/m2 46h continuous infusion (ci) ; the first 3 cy were delivered during RT, the 3 other after. In Arm B, pts received 4 cy: cisplatin 75 mg/m2 d1 followed by 5FU 1,000 mg/m2/d ci d1-4, the first 2 cy during RT and 2 other after. The primary endpoint was PFS. Main secondary endpoints were OS, grade 3-4 toxicities, and quality of life. A total of 266 pts would provide 90% power to detect a 20% 3y-PFS difference (α=0.05). Results: 267 pts were enrolled between 10/2004 and 08/2011. Treatment cohorts were well balanced: male 81%; median age 61 y; PS 0 53%, squamous cell 85.8%, stage III 52%, IVA 6.0% and IVB 3.0%. Full treatment was delivered to 67.9% and 72.2% of pts in arms A/B, respectively. 7 toxic deaths occurred in each arm. Grade 3/4 toxicities per pt (%) in arms A/B were neutropenia 30.6/31.3, febrile neutropenia 5.3/7.0, anemia 5.4/11.0, asthenia 17.6/10.2, respectively. The median FU time was 25.3 mos. 3y-PFS was 18.2/17.4 % (HR=1.07; 95%CI =0.80-1.43) and median OS was 20.2 /17.5 m (HR=1.06; 95%CI =0.77-1.46). Conclusions: CRT with FOLFOX does not improve PFS compared to cisplatin and 5-FU and has similar toxicities.

Randomized Phase III Trial of Whole-Abdominal Irradiation Versus Doxorubicin and Cisplatin Chemotherapy in Advanced Endometrial Carcinoma: A Gynecologic Oncology Group Study

2006 ◽  
Vol 24 (1) ◽  
pp. 36-44 ◽  
Author(s):  
Marcus E. Randall ◽  
Virginia L. Filiaci ◽  
Hyman Muss ◽  
Nick M. Spirtos ◽  
Robert S. Mannel ◽  
...  
Keyword(s):  
Endometrial Carcinoma ◽  
Residual Disease ◽  
Gynecologic Oncology ◽  
Hazard Ratio ◽  
Phase Iii ◽  
Gynecologic Oncology Group ◽  
Whole Abdominal Irradiation ◽  
Irradiation Dosage ◽  
To Receive ◽  
Abdominal Irradiation

Purpose To compare whole-abdominal irradiation (WAI) and doxorubicin-cisplatin (AP) chemotherapy in women with stage III or IV endometrial carcinoma having a maximum of 2 cm of postoperative residual disease. Patients and Methods Four hundred twenty-two patients were entered onto this trial. Of 396 assessable patients, 202 were randomly allocated to receive WAI, and 194 were allocated to receive AP. Irradiation dosage was 30 Gy in 20 fractions, with a 15-Gy boost. Chemotherapy consisted of doxorubicin 60 mg/m2 and cisplatin 50 mg/m2 every 3 weeks for seven cycles, followed by one cycle of cisplatin. Results Most patient and tumor characteristics were well balanced. The median patient age was 63 years; 50% had endometrioid tumors. Median follow-up time was 74 months. The hazard ratio for progression adjusted for stage was 0.71 favoring AP (95% CI, 0.55 to 0.91; P < .01). At 60 months, 50% of patients receiving AP were predicted to be alive and disease free when adjusting for stage compared with 38% of patients receiving WAI. The stage-adjusted death hazard ratio was 0.68 (95% CI, 0.52 to 0.89; P < .01) favoring AP. Moreover, at 60 months and adjusting for stage, 55% of AP patients were predicted to be alive compared with 42% of WAI patients. Greater acute toxicity was seen with AP. Treatment probably contributed to the deaths of eight patients (4%) on the AP arm and five patients (2%) on the WAI arm. Conclusion Chemotherapy with AP significantly improved progression-free and overall survival compared with WAI. Nevertheless, further advances in efficacy and reduction in toxicity are clearly needed.

Baseline quality of life (QOL) as a predictor of tolerance to intraperitoneal (IP) chemotherapy for advanced epithelial ovarian cancer (EOC): A Gynecologic Oncology Group (GOG) study

2006 ◽  
Vol 24 (18_suppl) ◽  
pp. 5007-5007 ◽  
Author(s):  
L. B. Wenzel ◽  
H. Q. Huang ◽  
D. K. Armstrong ◽  
J. L. Walker ◽  
D. Cella
Keyword(s):  
Residual Disease ◽  
Performance Status ◽  
Gynecologic Oncology ◽  
Self Report ◽  
Phase Iii ◽  
Gynecologic Oncology Group ◽  
Patient Reported ◽  
Chemotherapy Patients ◽  
One Year ◽  
Number Of Cycles

5007 Background: A recent GOG randomized phase III trial demonstrated a 16 month improvement in survival for women with optimally debulked stage III EOC. Patients on the IP chemotherapy arm experienced a survival advantage but significantly worse toxicities, worse QOL during treatment, and more neurotoxicity (NTX) one year later, compared to those on the IV arm. We sought to determine whether baseline QOL and NTX and abdominal discomfort (AD) predict severity of IP treatment-related adverse effects and number of cycles completed. Methods: Three self-report QOL measures were utilized: the FACT-O (39 items), and FACT/GOG-NTX (11 items) and FACT/GOG-AD (4 items) subscales. Scoring was on a 5-point scale, with higher scores representing better QOL (FACT-O) whereas higher scores indicated worse symptoms (-NTX and -AD subscales). In addition to NTX and AD, we explored associations with fatigue. A logistic regression model was used for the analyses. Results: Of 205 patients randomly assigned to receive IP chemotherapy, 198 (97%) completed baseline QOL assessments, of whom 83 (42%) completed all 6 cycles and 16 (8%) completed none. Adjusting for age, performance status and residual disease, patients reporting higher baseline FACT-O and lower -NTX and -AD scores were more likely to complete more IP cycles. Categorizing FACT-O scores by quartiles (≤92, 93 to ≤108.8, 109 to ≤121.1, and >121.1), patients in the lowest quartile were significantly less likely to complete 6 cycles of IP therapy (odds ratio [OR] = 4.46; 95% CI: 1.95–10.21, p < 0.001). Higher FACT-O scores were also associated with less grade 3–4 fatigue (OR = 0.81 per 10 points; 95% CI: 0.67–0.99; p = 0.037); however, there was no relationship between baseline NTX and AD subscale scores and severity of physician-rated NTX and AD. Conclusions: Baseline patient-reported QOL and NTX and AD symptoms predict tolerance to IP chemotherapy. Patients with the poorest baseline QOL (FACT-O score <92) were least likely to complete IP therapy. No significant financial relationships to disclose.

The influence of renal function on gemcitabine-based chemotherapy for advanced biliary tract cancer: An exploratory subgroup analysis of JCOG1113.

2019 ◽  
Vol 37 (4_suppl) ◽  
pp. 368-368
Author(s):  
Makoto Ueno ◽  
Chigusa Morizane ◽  
Takuji Okusaka ◽  
Gakuto Ogawa ◽  
Yuya Sato ◽  
...  
Keyword(s):  
Renal Function ◽  
Biliary Tract ◽  
Biliary Tract Cancer ◽  
Cox Regression ◽  
Progression Free Survival ◽  
Phase Iii ◽  
Eligibility Criteria ◽  
Tract Cancer ◽  
Grade 3 ◽  
The Impact

368 Background: JCOG1113 is a randomized phase III trial to evaluate gemcitabine (GEM) plus S-1 (GS) versus GEM plus cisplatin (GC) regarding overall survival (OS) for advanced biliary tract cancer (BTC) (UMIN000001685) and the non-inferiority of GS was demonstrated. It is necessary to consider renal function using cisplatin or S-1 because cisplatin has renal toxicity, and the toxicity of S-1 is affected by renal function. Therefore, we evaluated the influence of renal function on the efficacy and safety of GC and GS in JCOG1113. Methods: All enrolled patients (pts) in JCOG1113 (n = 354) were analyzed. Eligibility criteria included chemotherapy-naïve pts with recurrent or unresectable biliary tract adenocarcinoma, ECOG-PS of 0–1, CCr > 50 ml/min, and adequate organ function. Renal function was classified into two groups by creatinine clearance (CCr) as calculated by the Cockcroft-Gault formula; high CCr (CCr ≥ 80 ml/min) or low CCr (80 > CCr ≥ 50 ml/min). The impact of renal function on OS and progression-free survival (PFS) were compared using the Cox regression model. The adverse events (AEs) were compared using Fisher’s exact test. Results: Eighty-eight pts on GC and 88 pts on GS were included in the high CCr group, and 87 pts on GC and 91 pts on GS were included in the low CCr group. There were no differences between the groups regarding, sex, PS, primary site, biliary drainage, operation, or recurrence, except for age. The hazard ratio (HR) of GS to GC for OS was 1.12 (95% CI 0.81–1.56) in the high CCr group and 0.80 (95% CI 0.58–1.11) in the low CCr group. The HR of GS to GC for PFS was 1.06 (95% CI 0.78–1.44) in the high CCr group and 0.69 (95% CI 0.50–0.94) in the low CCr group. Grade 3-4 AEs of white blood cell count decreased (35.3%/23.6%), anemia (29.4%/7.9%) and platelet count decreased (18.8%/10.1%) were more common in GC than GS in the low CCr group. In contrast, the incidence of all grade 3-4 non-hematological AEs was higher (36.0%/11.8%) in GS than GC in the low CCr group ( p = 0.0002). Conclusions: GS was better in terms of OS, PFS, and hematological toxicities than GC in the low CCr group. GS might be recommended for the population with lower renal function in the treatment for advanced BTC.

Randomized Phase III Trial of Cisplatin With or Without Topotecan in Carcinoma of the Uterine Cervix: A Gynecologic Oncology Group Study

2005 ◽  
Vol 23 (21) ◽  
pp. 4626-4633 ◽  
Author(s):  
Harry J. Long ◽  
Brian N. Bundy ◽  
Edward C. Grendys ◽  
Jo Ann Benda ◽  
D. Scott McMeekin ◽  
...  
Keyword(s):  
Gynecologic Oncology ◽  
Progression Free Survival ◽  
Data Safety Monitoring Board ◽  
Cervix Cancer ◽  
Phase Iii ◽  
Hematologic Toxicity ◽  
Gynecologic Oncology Group ◽  
Phase Iii Trial ◽  
Grade 3

Purpose On the basis of reported activity of methotrexate, vinblastine, doxorubicin, and cisplatin (MVAC) or topotecan plus cisplatin in advanced cervix cancer, we undertook a randomized trial comparing these combinations versus cisplatin alone, to determine whether survival is improved with either combination compared with cisplatin alone, and to compare toxicities and quality of life (QOL) among the regimens. Patients and Methods Eligible patients were randomly allocated to receive cisplatin 50 mg/m2 every 3 weeks (CPT); cisplatin 50 mg/m2 day 1 plus topotecan 0.75 mg/m2 days 1 to 3 every 3 weeks (CT); or methotrexate 30 mg/m2 days 1, 15, and 22, vinblastine 3 mg/m2 days 2, 15, and 22, doxorubicin 30 mg/m2 day 2, and cisplatin 70 mg/m2 day 2 every 4 weeks (MVAC). Survival was the primary end point; response rate and progression-free survival (PFS) were secondary end points. QOL data are reported separately. Results The MVAC arm was closed by the Data Safety Monitoring Board after four treatment-related deaths occurred among 63 patients, and is not included in this analysis. Two hundred ninety-four patients enrolled onto the remaining regimens: 146 to CPT and 147 to CT. Grade 3 to 4 hematologic toxicity was more common with CT. Patients receiving CT had statistically superior outcomes to those receiving CPT, with median overall survival of 9.4 and 6.5 months (P = .017), median PFS of 4.6 and 2.9 months (P = .014), and response rates of 27% and 13%, respectively. Conclusion This is the first randomized phase III trial to demonstrate a survival advantage for combination chemotherapy over cisplatin alone in advanced cervix cancer.

Adjuvant Treatment for Early Ovarian Cancer: A Randomized Phase III Trial of Intraperitoneal 32P or Intravenous Cyclophosphamide and Cisplatin—A Gynecologic Oncology Group Study

2003 ◽  
Vol 21 (23) ◽  
pp. 4350-4355 ◽  
Author(s):  
Robert C. Young ◽  
Mark F. Brady ◽  
Roberta K. Nieberg ◽  
Harry J. Long ◽  
Allan R. Mayer ◽  
...  
Keyword(s):  
Ovarian Cancer ◽  
High Risk ◽  
Cumulative Incidence ◽  
Residual Disease ◽  
Gynecologic Oncology ◽  
Stage Ii ◽  
Phase Iii ◽  
Gynecologic Oncology Group ◽  
Gynecology And Obstetrics ◽  
Early Ovarian Cancer

Purpose: To conduct a prospective study of intraperitoneal radioactive chromic phosphate (32P) versus cyclophosphamide-cisplatin (CP) in women with early ovarian cancer at high risk for recurrence (International Federation of Gynecology and Obstetrics stage Ia or Ib grade 3 or Ic or stage II, no macroscopic residual disease) and to compare cumulative incidence of recurrence, overall survival, and relative toxicity. Materials and Methods: A total of 251 patients were randomly assigned to treatment with 32P or CP. Twenty-two (8.7%) were ineligible following centralized pathology review. Of the 229 patients included in the analysis, 110 received 32P, and 119 received CP. Results: The cumulative incidence of recurrence at 10 years was 35% (95% CI, 27% to 45%) for patients receiving 32P and 28% (95% CI, 21% to 38%) for those receiving CP. Patients receiving CP had a recurrence rate 29% lower than that of those receiving 32P (P = .15, two-tail test). The death rate for patients treated with CP was 17% lower than that for patients treated with 32P (difference not significant). Combining both arms, the 10-year cumulative incidence of recurrence for all stage I patients was 27% (95% CI, 20% to 34%) compared with 44% (95% CI, 32% to 56%) for stage II patients (P = .01). Both regimens were reasonably well tolerated, but problems with inadequate distribution (7%) and small-bowel perforation (3%) make the otherwise less toxic 32P less acceptable. Conclusion: Although there are no statistically significant differences in survival, the lower cumulative recurrence seen with CP and complications of 32P administration make platinum-based combinations the preferred adjuvant therapy for early ovarian cancer patients at high-risk for recurrence.

scholarly journals Phase III Trial of Weekly Methotrexate or Pulsed Dactinomycin for Low-Risk Gestational Trophoblastic Neoplasia: A Gynecologic Oncology Group Study

2011 ◽  
Vol 29 (7) ◽  
pp. 825-831 ◽  
Author(s):  
Raymond J. Osborne ◽  
Virginia Filiaci ◽  
Julian C. Schink ◽  
Robert S. Mannel ◽  
Angeles Alvarez Secord ◽  
...  
Keyword(s):  
Risk Score ◽  
Gynecologic Oncology ◽  
Complete Response ◽  
Primary Treatment ◽  
Low Risk ◽  
Phase Iii ◽  
Gynecologic Oncology Group ◽  
Gestational Trophoblastic Neoplasia ◽  
Oncology Group ◽  
Phase Iii Trial

Purpose There is no consensus on the best regimen for the primary treatment of low-risk gestational trophoblastic neoplasia (GTN). Patients and Methods Two commonly used single-drug regimens were compared with respect to the proportion of patients meeting the criteria for a complete response (CR) in a randomized phase III trial conducted by the Gynecologic Oncology Group. Eligibility was purposefully broad to maximize the generalizability of the results and included patients with a WHO risk score of 0 to 6 and patients with metastatic disease (limited to lung lesions < 2 cm, adnexa, or vagina) or choriocarcinoma. Results Two hundred forty women were enrolled, and 216 were deemed eligible. Biweekly intravenous dactinomycin 1.25 mg/m2 was statistically superior to weekly intramuscular (IM) methotrexate 30 mg/m2 (CR: 70% v 53%; P = .01). Similarly, in patients with low-risk GTN as defined before the 2002 WHO risk score revisions (risk score of 0 to 4 and excluding choriocarcinoma), response was 58% and 73% in the methotrexate and dactinomycin arms, respectively (P = .03). Both regimens were less effective if the WHO risk score was 5 or 6 or if the diagnosis was choriocarcinoma (CR: 9% and 42%, respectively). There were two potential recurrences; one at 4 months (dactinomycin) and one at 22 months (methotrexate). Not all patients completed follow-up. Both regimens were well tolerated. Conclusion The biweekly dactinomycin regimen has a higher CR rate than the weekly IM methotrexate regimen in low-risk GTN, a generally curable disease.

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