- Email: [email protected]
Chemotherapy, early surgical reassessment, and hyperfractionated abdominal radiotherapy in stage III ovarian cancer: Results of a gynecologic oncology group trial
192
Radiation Oncology, Biology, Physics
Volume 30, Supplement 1
68 CHEMOTHERAPY, EARLY SURGICAL REASSESSMENT, AND HYPERFRACTIONATED ABDOMINAL RADIOTHERAPY IN STAGE III OVARIAN CANCER: RESULTS OF A GYNECOLOGIC ONCOLOGY GROUP TRIAL Marcus Randall', Rolland Barrett*, Nick M. Spirtos', Eva Chalas4, Howard Homesley', Samuel Lentz* AFFILITATION: 'Indiana University School of Medicine, 'Bowman Gray School of Medicine of Wake Forest University, 'Women's Cancer Center, 4State University of New York. PURPOSE: To determine outcomes and treatment toxicities in patients with optimal stage III ovarian carcinoma treated with 3 courses of cisplatin (70-75 mg/ml) and cyclophosphamide (500-750 mg/m2), surgical reassessment (SRA) and hyperfractionated whole abdominal irradiation (WAI) (80 cGy b.i.d. to 30.4 Gy). MATERIALS AND METHODS: Forty two eligible patients entered this prospective phase II study conducted by the Gynecologic Oncology Group. The age range was 32-76 years (median 58). Disease characteristics were as follows: stage-IIIA (2%), IIIB (7%), IIIC (90%); histology-serous papillary (64%), endometrioid (19%), mixed or other (17%); grade-l (5%), 2 (30%), 3 (65%); residual after initial surgery-none (38%), -c lcm (62%). Five patients (12%) progressed while on chemotherapy and were not eligible for WAI. Of the 37 remaining patients, 35 received WAI. SRA was not performed in 5 patients. RESULTS: Results of SRA were as follows: macroscopically +, 21 (57%), microscopically +, 4 (ll%), negative, 12 (32%). Of 23 patients with macroscopic residual disease after initial laparotomy, 16 (70%) had macroscopically positive SRA's. Of 14 patients with no macroscopic residual, SRA's were macroscopically positive in 8 (57%), indicating tumor progression. Of 16 patients with macroscopically + SRA's completing WAI, 5 (31%) are progression-free at 11-32 months. Of 15 patients with negative SRA's or refusing SRA and completing WAI, 7 (47%) are progression-free at 22-39 months. Considering the 35 patients who completed chemotherapy and WAI, disease status is: no evidence of disease -13 (37%); alive with disease -7 (20%); dead with disease -14 (40%); and dead of intercurrent death -1 (3%). SRA status was predictive of outcome; negative-median PFS=47mo., positive-median PFS=12 mo., p=O.O019. Median overall and progression-free survivals (PFS) are 46 and 23 months, respectively. Toxicity during WA1 was limited and reversible. Following WAI, 7 patients underwent lqparotomies for abdominal symptoms; 6 had recurrent disease. Five additional patients developed partial small bowel obstruction or malabsorption not requiring surgery, of whom 3 subsequently developed recurrence. CONCLUSIONS: l)Tumor progression often occurs early during cisplatin-cyclophosphamide chemotherapy. 2)Hyperfractionated WA1 after limited chemotherapy appears to benefit some patients with residual disease at SRA. 3)Hyperfractionated WA1 is well tolerated acutely and produces few late effects directly attributable to WAI. 4)The results of this trial compare favorably to GOG trials using chemotherapy alone.
69 QUALITY OF LIFE ASSESSMENT IN WOMEN AFTER CONSERVATION FOR INVASIVE BLADDER CANCER
COMBINED
MODALITY TREATMENT WITH BLADDER
L. A. Kachnicl, W. U. Shipleyl, P. P. Griffin*, A. L. Zietmanl, J. J. Coenl, C. M. Mannixl, D. S. Kaufman3 lGenitourinary Oncology Unit, Dept. of Radiation Oncology, *Dept. of Urology, 3Dept. of Medical Oncology, Massachusetts General Hospital, Harvard Medical School, Boston, MA 02114
Purpose/Objective: An assessment of global and specific quality of life (QOL) issues by structured retrospective patient interviews in women with invasive bladder carcinoma treated on combined modality organ sparing protocols. Materials and Methoda: Patients with muscle-invading (stages T2-4, Nx, MO) bladder cancer who met appropriate eligibility criteria were treated with maximal TUR followed by induction chemoradiotherapy (cisplatin 70 or 100 mg/m* x 2 plus 40 Gy pelvic lo-25 MV irradiation, 18 patients) or the same preceeded by 2 cycles of methotrexate, cisplatin and vinblastine, (23 patients). The tumor response was then evaluated by cystoscopy, cytology and biopsy. Complete responders and all noncystectomy candidates received consolidation by additional cisplatin and tumor boost to 64.8 Gy. Incomplete responders underwent immediate radical cystectomy. There were 11 T2, Nx, MO tumors (52%), 9 T3 (43%) and 1 T4 (5%). All tumors were transitional cell histology with 4 moderately (19%) and 17 poorly differentiated (81%). 42 women patients were selected for bladder preservation and 21 of these (mean age 66 years, range 37-87, with 1-81 months of follow-up, median 56, since completion of consolidation chemo-radiotherapy) underwent a structured interview of QOL issues including global, bladder, bowel and sexual patterns. 21 patients were not interviewed; death from metastatic disease (12) or from intercurrent disease (3), undergone cystectomy for local recurrence (4), unavailable (2). A quantified symptom score (i.e. bladder frequency: O=>Q3hrs, l=Q2-3hrs, 2=Ql-2hrs and 3=
Radiation Oncology, Biology, Physics
Volume 30, Supplement 1
68 CHEMOTHERAPY, EARLY SURGICAL REASSESSMENT, AND HYPERFRACTIONATED ABDOMINAL RADIOTHERAPY IN STAGE III OVARIAN CANCER: RESULTS OF A GYNECOLOGIC ONCOLOGY GROUP TRIAL Marcus Randall', Rolland Barrett*, Nick M. Spirtos', Eva Chalas4, Howard Homesley', Samuel Lentz* AFFILITATION: 'Indiana University School of Medicine, 'Bowman Gray School of Medicine of Wake Forest University, 'Women's Cancer Center, 4State University of New York. PURPOSE: To determine outcomes and treatment toxicities in patients with optimal stage III ovarian carcinoma treated with 3 courses of cisplatin (70-75 mg/ml) and cyclophosphamide (500-750 mg/m2), surgical reassessment (SRA) and hyperfractionated whole abdominal irradiation (WAI) (80 cGy b.i.d. to 30.4 Gy). MATERIALS AND METHODS: Forty two eligible patients entered this prospective phase II study conducted by the Gynecologic Oncology Group. The age range was 32-76 years (median 58). Disease characteristics were as follows: stage-IIIA (2%), IIIB (7%), IIIC (90%); histology-serous papillary (64%), endometrioid (19%), mixed or other (17%); grade-l (5%), 2 (30%), 3 (65%); residual after initial surgery-none (38%), -c lcm (62%). Five patients (12%) progressed while on chemotherapy and were not eligible for WAI. Of the 37 remaining patients, 35 received WAI. SRA was not performed in 5 patients. RESULTS: Results of SRA were as follows: macroscopically +, 21 (57%), microscopically +, 4 (ll%), negative, 12 (32%). Of 23 patients with macroscopic residual disease after initial laparotomy, 16 (70%) had macroscopically positive SRA's. Of 14 patients with no macroscopic residual, SRA's were macroscopically positive in 8 (57%), indicating tumor progression. Of 16 patients with macroscopically + SRA's completing WAI, 5 (31%) are progression-free at 11-32 months. Of 15 patients with negative SRA's or refusing SRA and completing WAI, 7 (47%) are progression-free at 22-39 months. Considering the 35 patients who completed chemotherapy and WAI, disease status is: no evidence of disease -13 (37%); alive with disease -7 (20%); dead with disease -14 (40%); and dead of intercurrent death -1 (3%). SRA status was predictive of outcome; negative-median PFS=47mo., positive-median PFS=12 mo., p=O.O019. Median overall and progression-free survivals (PFS) are 46 and 23 months, respectively. Toxicity during WA1 was limited and reversible. Following WAI, 7 patients underwent lqparotomies for abdominal symptoms; 6 had recurrent disease. Five additional patients developed partial small bowel obstruction or malabsorption not requiring surgery, of whom 3 subsequently developed recurrence. CONCLUSIONS: l)Tumor progression often occurs early during cisplatin-cyclophosphamide chemotherapy. 2)Hyperfractionated WA1 after limited chemotherapy appears to benefit some patients with residual disease at SRA. 3)Hyperfractionated WA1 is well tolerated acutely and produces few late effects directly attributable to WAI. 4)The results of this trial compare favorably to GOG trials using chemotherapy alone.
69 QUALITY OF LIFE ASSESSMENT IN WOMEN AFTER CONSERVATION FOR INVASIVE BLADDER CANCER
COMBINED
MODALITY TREATMENT WITH BLADDER
L. A. Kachnicl, W. U. Shipleyl, P. P. Griffin*, A. L. Zietmanl, J. J. Coenl, C. M. Mannixl, D. S. Kaufman3 lGenitourinary Oncology Unit, Dept. of Radiation Oncology, *Dept. of Urology, 3Dept. of Medical Oncology, Massachusetts General Hospital, Harvard Medical School, Boston, MA 02114
Purpose/Objective: An assessment of global and specific quality of life (QOL) issues by structured retrospective patient interviews in women with invasive bladder carcinoma treated on combined modality organ sparing protocols. Materials and Methoda: Patients with muscle-invading (stages T2-4, Nx, MO) bladder cancer who met appropriate eligibility criteria were treated with maximal TUR followed by induction chemoradiotherapy (cisplatin 70 or 100 mg/m* x 2 plus 40 Gy pelvic lo-25 MV irradiation, 18 patients) or the same preceeded by 2 cycles of methotrexate, cisplatin and vinblastine, (23 patients). The tumor response was then evaluated by cystoscopy, cytology and biopsy. Complete responders and all noncystectomy candidates received consolidation by additional cisplatin and tumor boost to 64.8 Gy. Incomplete responders underwent immediate radical cystectomy. There were 11 T2, Nx, MO tumors (52%), 9 T3 (43%) and 1 T4 (5%). All tumors were transitional cell histology with 4 moderately (19%) and 17 poorly differentiated (81%). 42 women patients were selected for bladder preservation and 21 of these (mean age 66 years, range 37-87, with 1-81 months of follow-up, median 56, since completion of consolidation chemo-radiotherapy) underwent a structured interview of QOL issues including global, bladder, bowel and sexual patterns. 21 patients were not interviewed; death from metastatic disease (12) or from intercurrent disease (3), undergone cystectomy for local recurrence (4), unavailable (2). A quantified symptom score (i.e. bladder frequency: O=>Q3hrs, l=Q2-3hrs, 2=Ql-2hrs and 3=