8 High-dose megestrol acetate in advanced ovarian cancer: A phase II study

1987 ◽  
Vol 28 ◽  
pp. 215
Author(s):  
C.H.N. Veenhof ◽  
M.E.L. van der Burg ◽  
F. Carnino ◽  
M. Forni ◽  
C.F. de Oliveira ◽  
...  



1998 ◽  
Vol 16 (5) ◽  
pp. 1852-1860 ◽  
Author(s):  
C Aghajanian ◽  
D Fennelly ◽  
F Shapiro ◽  
R Waltzman ◽  
L Almadrones ◽  
...  

PURPOSE We performed a pilot phase II study to evaluate the potential for delivery of rapidly sequenced high-dose chemotherapy treatments rescued with autologous peripheral-blood progenitor cells (PBP) in patients with previously untreated, advanced ovarian cancer. PATIENTS AND METHODS A single cycle of mobilization was used, primed with cyclophosphamide (CPA)/paclitaxel (Txl) and filgrastim (granulocyte colony-stimulating factor [G-CSF]), followed by three cycles of high-dose carboplatin (CBDCA)/Txl and one cycle of high-dose melphalan (MEL), each rescued by PBP. We then analyzed the outcome for a total of 56 consecutive patients treated with high-dose chemotherapy as part of this program. RESULTS In the phase II pilot, 21 patients were enrolled. There were no treatment-related deaths through 98 high-dose treatments, although 34 treatments were complicated by hospitalization, primarily for neutropenic fever. Seventy-six percent of patients experienced grade 3 to 4 gastrointestinal toxicity and 62% experienced grade 2 to 3 neuropathy. Five of 15 (33%) patients who underwent second-look surgery attained a pathologic complete response. In the overall analysis, 56 patients were reviewed. Forty-four patients were assessable for response by second-look surgery or clinical progression. Fifteen of 44 patients achieved a pathologic complete response (34%). The pathologic complete response rate in optimal-disease patients was 12 of 22 (55%), while only three of 22 (13%) suboptimal stage III and IV patients achieved a pathologic complete response. CONCLUSION The Gynecologic Oncology Group has initiated a pilot phase II trial of this approach in patients with optimally debulked stage III ovarian cancer. There is no evidence to support the use of this or other aggressive regimens outside of a clinical trial.



2001 ◽  
Vol 12 (9) ◽  
pp. 719-724 ◽  
Author(s):  
Sarikapan Wilailak ◽  
Vasant Linasmita ◽  
Somkeart Srisupundit


2000 ◽  
Vol 5 (2) ◽  
pp. 85-88
Author(s):  
T. Sugiyama ◽  
M. Yakushiji ◽  
Y. Aoki ◽  
K. Tanaka ◽  
R. Nishimura ◽  
...  




2006 ◽  
Vol 100 (2) ◽  
pp. 318-323 ◽  
Author(s):  
M.O. Nicoletto ◽  
C. Falci ◽  
D. Pianalto ◽  
G. Artioli ◽  
P. Azzoni ◽  
...  


2006 ◽  
Vol 24 (18_suppl) ◽  
pp. 15062-15062
Author(s):  
G. Bolis ◽  
G. Polverino ◽  
C. Sciatta ◽  
G. Scarfone ◽  
G. Scambia

15062 Background: Patients (pts) with newly diagnosed AOC generally receive platinum plus taxane therapy. G represents a new active agent to improve the standard regimen. To investigate the safety of two schedules of induction treatments both followed by triplet PCG we have drafted a phase II study. Methods: 14 pts, suboptimally debulked (FIGO stage IIIc) entered the study. HDC ( AUC 7,5) was administered for 2 courses every 21 days ( arm A) and P ( 80 mg/sqm, d 1,8,15,22) + G ( 2500 mg/sqm, d 1,15) (arm B). Both regimens have been followed by standard triplet P ( 175 mg/sqm, d1) + C ( AUC 5, d1) + G ( 800 mg/sqm, d1,8) every 21 days for a total of 6 courses. Antiemetics, corticoids, antihistaminics and ranitidine have been added. Results: The median age was 57 y (39–68). Histology was serous in 64.3%, mixed 14.3% and other 21.4%. All pts had Grade 3 tumor but one. Seven pts received arm A schedule and 7 arm B both followed by PCG regimen. Worst haematological toxicities ( in term of nadir) observed in all courses for all pts were neutropenia G4 ( 42.8% arm A vs 71.4% arm B), anemia G2 (71.4% arm A vs 57.1% arm B), thrombocytopenia G2 ( 57.1% arm A vs 42.8% arm B). Most common non haematological toxicities were alopecia and mild nausea/vomiting. Mild paresthesias in both regimens were observed. No sepsis or neutropenic fever nor unespected toxicity or treatment-related deaths were observed. 71.4% of pts completed foreseen schedules of treatments. 78.5% of pts received erytropoietin and 28.5% G-CSF support. Conclusions: HDC and weekly PG followed by triplet PCG are feasible and safety regimens in AOC pts ( residual disease > 1 cm). Further phase II-III setting study using these schedules will be conducted. No significant financial relationships to disclose.



2010 ◽  
Vol 28 (15_suppl) ◽  
pp. 5015-5015
Author(s):  
R. W. Holloway ◽  
M. Roche ◽  
L. DeMars ◽  
J. A. Williams ◽  
A. Enke ◽  
...  




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