Biomedical subjects

G P Cima

Publications and source records attributed to G P Cima.

4 recordsLinked to original sources

PubMed2004

A Randomized Study of Epithelial Ovarian Cancer: Is Chemotherapy Useful after Complete Remission?

Objective. The aim of this study is to verify whether consolidation chemotherapy with Cisplatin improves disease-free survival and/or overall survival in patients affected by epithelial ovarian cancer.Methods. A multicenter study examined 122 randomized patients in complete remission as judged by laparoscopy or laparotomy following first-line chemotherapy consisting of ACy (Adriamycin + Cyclophosphamide), PCy (Cisplatin + Cyclophosphamide), or Mitoxantrone + Carboplatin. Sixty-one of these patients were treated with 3 cycles of 5-Fluorouracil (FU) 500 mg/m2 for 5 days followed by Cisplatin at 100 mg/m2 on the 6th or 7th day every 28 days; the other 61 received no further treatment (nihil group).Results. Sixty patients in the Cisplatin arm were evaluable. There were 36 relapses in the FU+Cisplatin arm and 30 in the nihil arm. Peritoneal relapses were 25% for Cisplatin treatment vs. 16.4 % for nihil. There were 29 deaths in the Cisplatin arm vs. 27 for nihil. Median overall survival time (95 months with Cisplatin vs. 96 months in the nihil group) and median disease-free survival (66 months with Cisplatin vs. 73 in the nihil group) were similar in both arms (p=0.66 and p=0.41, respectively). There were no significant differences in tumor stage and grade between the two arms. Seven patients presented a second neoplasm during follow-up: six in the nihil arm, but only one patient in the Cisplatin arm. Death in these patients was due to the second neoplasm and not to progression of ovarian cancer.Conclusion. Three courses of additional platinum+FU treatment after five cycles of first-line chemotherapy without FU produced no increase in overall survival or disease-free survival.

Journal Article↗

PubMed1997

Surgical second look in ovarian cancer: a randomized study in patients with laparoscopic complete remission--a Northeastern Oncology Cooperative Group-Ovarian Cancer Cooperative Group Study.

PURPOSE: The usefulness of extensive and repetitive surgery for patients with ovarian cancer still remains unproven (at least for some conditions). We planned an accurate prospective test of the hypothesis that patients with advanced-stage disease, after they had reached a clinical complete remission (CR), may benefit from surgical second look (SSL). PATIENTS AND METHODS: One hundred two patients in CR (as assessed by clinical findings, markers, and visualization by computed tomographic [CT] scan and laparoscopy), after initial debulking and first-line chemotherapy, were randomized to two arms, which were well balanced for predictive criteria such as age, stage at presentation, histology, grading, date of randomization, and residua after first surgery. Forty-eight patients were randomly assigned to receive follow-up evaluation only, while 54 were assigned to receive second surgery (eight of them refused). Of 46 surgical patients, 35 had negative and 11 positive surgical findings (24% clinically false-negative). RESULTS: Despite the microscopic residua found at open surgery, and the fact that the patients were then treated with second-line chemotherapy, SSL did not increase the probability of survival in this setting. In an analysis of the results according to the intention-to-treat criteria, after a 60-month follow-up period, the overall survival rates in the two groups of patients (SSL v no SSL) were 65% and 78%, respectively (P = .14). Multivariate analysis according to predictive criteria confirmed there was no significant difference between the two groups (P = .39). CONCLUSION: Our study shows the following: (1) our second-line treatment is scarcely effective; (2) SSL accurately defines complete responders to first-line chemotherapy; (3) SSL per se does not prolong survival; and (4) if confirmed, a less invasive procedure could replace SSL as a valuable method in new first-line regimens in ovarian cancer patients with clinical CR confirmed by laparoscopy.

Female↗

PubMed1995

Prospective evaluation of calcium and estrogen administration on bone mass and metabolism after ovariectomy.

We evaluated the effects of low-dose ethinylestradiol administration in the prevention of the rapid bone loss that follows ovariectomy in women. After 10-30 days from surgery, patients received either a sole calcium supplementation 500 mg/day (n = 20) or ethinylestradiol 20 micrograms/day in addition to the same daily calcium supplement (n = 21), for 12 months. In the control group, urinary hydroxyproline excretion, serum alkaline phosphatase and plasma bone Gla protein levels presented a substantial (p < 0.05) increase, while radial bone density significantly (p < 0.05) decreased 6 months after surgery. In the ethinylestradiol-treated group, the patterns of biochemical markers indicated that ethinylestradiol can restrain the bone remodelling processes. Radial bone density showed no significant modification during the 12 months' study period. In conclusions, these results demonstrate that the administration of 20 micrograms/day of ethinylestradiol can prevent the rapid bone loss that follows ovariectomy.

Administration, Oral↗

PubMed1992

Experience with intraperitoneal alpha-2a interferon.

Eighteen patients affected with epithelial ovarian cancer have been treated by intraperitoneal alpha 2a-Interferon. The usual single dosage was 54 x 10(6) U at weekly intervals for four times (eight times in responders): 10 histologically confirmed complete remissions and 3 partial remissions have been obtained; the toxicity was represented by fever in the majority of the cases, by abdominal discomfort in some cases, and by a mild transitory neurological complication in 1 case. Seventeen of 18 patients were pretreated, and 11 of 18 had only cytologic and/or microscopic disease. alpha 2a-Interferon has proven to be very effective and moderately toxic in microscopic peritoneal disease of ovarian epithelial cancer previously treated with extensive surgery and intravenous cytotoxic chemotherapy.

Female↗