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Biomedical subjects

F Odicino

Publications and source records attributed to F Odicino.

At least 37 records · Page 2Linked to original sources

Early stage ovarian cancer: the Italian contribution to clinical research. An update.

Early ovarian cancer (stages IA-IIA) accounts for 30% of all epithelial ovarian cancer. Even if relatively uncommon, when "high risk" patients are considered, it is lethal in 25-30% of the cases. Mainstay of treatment is surgery followed by either adjuvant chemotherapy or radiotherapy when indicated on the basis of still debatable prognostic factors. Literature data show a great variability in survival rate due to the great heterogeneity of patients considered in different reports and few randomized trials affected by a consequent low power. Italian groups have contributed both in investigating the role of surgery and of chemo or radiotherapy in the treatment of this disease. An important contribution in surgery has been made by Italian institutions in reducing the extent of surgery in young patients wishing to retain their reproductive capability showing that a "conservative surgery" (unilateral oophorectomy) can be safely performed in initial stages without affecting the probability of cure. Another important surgical topic investigated by Italian institutions concerns the role of lymphadenectomy. In early ovarian cancer the node involvement ranges between 14-24% in stage I and 37-50% in stage II. Although the node positivity rate detectable by sampling (SA) is lower than the one shown by a systematic procedure (LY), no data at the moment show that patients undergoing a sampling evaluation have a poorer prognosis. From 1992 through 1994, 202 patients (SA: 99; LY: 103) were enrolled by six Italian institutions in a randomized trial aimed to assess the diagnostic and therapeutic role of SA vs. LY in early stage ovarian cancer. Positive nodes were detected in 9.9% vs. 19.3% respectively as well as a different proportion of intra/perioperative complications occurred. No difference in time to relapse nor in overall survival were detected in the two groups showing no evidence of efficacy in favor of extensive staging of the retroperitoneum. From 1983 to 1990, 271 stage I ovarian cancer patients entered two prospective multicentric randomized trials conducted by Italian institutions. Trial I compared cisplatin (50 mg/m2, six cycles repeated every 28 days) vs. no further treatment in stage IA-B grade 2-3 patients; Trial II compared the same dose and schedule of cisplatin vs. intraperitoneal P32 in stage IC patients. Cisplatin significantly reduced the relapse rate by 65% in Trial I and by 61% in Trial II, but survival was not affected (Trial I: HR = 1.15, 95% CI = 0.44-2.98; Trial II: HR = 0.72, 95% CI = 0.37-1.43). The final conclusion drawn by these two important Italian studies was that adjuvant cisplatin treatment in early ovarian cancer prevents relapse although the impact of chemotherapy remains unclear. For this reason two international trials have been performed (ICON1 and ACTION) aimed at assessing the role of platinum-based chemotherapy on survival. Italian collaboration in both trials has been important, including about half of the total number of the 900 randomized patients. Results will probably be available during this year and are expected with a great interest by the whole scientific international community.

Adult↗

Replacement therapy for breast cancer survivors. A pilot study.

BACKGROUND: Traditionally, breast cancer survivors were not considered as candidates for hormone replacement therapy (HRT) because of the possibility that an occult metastatic site of disease might be activated, thus negatively influencing the outcome for the patient. METHODS: A retrospective review of 77 breast cancer survivors who have taken HRT was conducted. RESULTS: Seven recurrences were reported among the 77 patients studied in-depth, with correlations to stage, age, and node and receptor status. There have been no recurrences among the 33 additional patients who were placed on the study after the completion of this analysis. CONCLUSIONS: No significant adverse outcome was detected in this group of breast cancer survivors receiving HRT. Given the established benefits of HRT, a reappraisal of this subject is necessary, and a prospective randomized trial is essential.

Adult↗

High-risk early-stage ovarian cancer. Randomized clinical trial comparing cisplatin plus cyclophosphamide versus whole abdominal radiotherapy.

From 1985 to 1989 70 patients with high-risk FIGO Stage I-II ovarian carcinoma entered a randomized trial comparing chemotherapy (CT: cisplatin 50 mg/m2 + cyclophosphamide 600 mg/m2 day 1 every 28 days for 6 courses) versus whole abdominal radiotherapy (WAR) given according to the open-field technique (43.2 Gy/24 fractions to the pelvis and 30.2 Gy to the upper abdomen). Protocol violations occurred in 8 patients randomized to WAR who received CT because of their own and/or physician's decision. Since protocol compliance was poor and accrual low the study was prematurely closed. Treatment-related toxicity for patients receiving CT was mild and tolerable, consisting chiefly of controllable grade 3 emesis (71%). Grade 3-4 diarrhea was experienced by 28% of patients treated with WAR; severe enteritis requiring hospitalization was observed in 2 patients. Late bowel obstruction requiring surgery was observed in 1 patient. At a median follow-up of 60 months, 21 patients died and 23 relapsed. Five-year survival was 71% and 53% (p = .16), while relapse-free survival was 74% and 50% (p = .07) for CT and WAR, respectively. Although no firm conclusion can be drawn from the present study, a short-term CT, including cisplatin, appears a safe treatment in comparison to WAR.

Abdomen↗

Randomized study comparing chemotherapy plus radiotherapy versus radiotherapy alone in FIGO stage IIB-III cervical carcinoma. GONO (North-West Oncologic Cooperative Group).

Between January 1989 and December 1991, 64 patients with advanced cervical carcinoma FIGO stage IIb-III were randomized to receive radiotherapy (RT) alone or the sequential combination of chemotherapy (CT) and RT. RT consisted of external RT (40 Gy fractionated over 4 weeks)+brachy-therapy (40 Gy to point A)+an additional boost to the parameters (15-20 Gy) in arm RT; CT consisted of cisplatin 60 mg/m2 i.v. day 1 q 15 days administered for 2 cycles before the start of RT and for 4 cycles after the end of radiation treatment in CT+RT arm. Among the 58 evaluable patients objective response rate was as follows: in RT arm, CR in 40.7% of patients, PR in 40.7%, and SD in 18.6%; in CT+RT arm, CR in 42% of patients, PR in 35.5%, and SD in 22.5%. The median duration of response was 12 months (range: 3-38 + months). At a median follow-up of 36 months survival (S) and progression-free survival (PFS) were 83% and 72.4% in RT arm, 72% and 59.3% in CT+RT arm, respectively. No significant difference was observed between the 2 treatment arms, neither in terms of objective response nor in terms of S and PFS. Both treatments were generally well tolerated. In our experience the addition of chemotherapy to standard radiotherapy does not enhance morbidity and does not interfere with the correct delivery of the planned treatment. However, results of this combined modality regimen remain unsatisfactory, since no improvement in pelvic control and survival of patients with advanced cervical carcinoma was observed.

Adult↗

Adjuvant cisplatin-based chemotherapy for stage I and II ovarian cancer: a 7-year experience.

87 patients with high risk of recurrence FIGO stage I and II ovarian carcinoma were treated with adjuvant chemotherapy consisting of cisplatin 50 mg/m2 plus cyclophosphamide 600 mg/m2 on day 1 every 28 days for 6 courses. Toxicity and efficacy of the regimen was evaluated after a median follow-up of 45 months. Treatment-related toxicity was mild and reversible, consisting chiefly of acute WHO grade 2 myelosuppression (10% of patients) and controllable grade 3 emesis (55%). No late toxicity was observed. Actuarial 7-year survival and relapse-free survival (RFS) were 76% and 61%, respectively; a statistically significant difference in outcome was observed for undifferentiated grade tumour (G1 vs. G2 vs. G3: P less than 0.01) but not for FIGO stage disease (stage I vs. stage II). In our opinion, short-term chemotherapy including the most active single agent, i.e. cisplatin, appears a tolerable and effective treatment which deserves further evaluation in large randomised trials.

Adult↗

Crossover study with cisplatin or carboplatin in advanced ovarian cancer.

Fifty-seven patients who had progressed during or relapsed after randomized first-line combination chemotherapy containing cisplatin or carboplatin were entered into a crossover study in which the analog not previously assigned was administered alone as salvage treatment. Carboplatin and cisplatin were administered at doses of 400 and 100 mg/m2, respectively, every 28 days. Among the 24 patients enrolled in the cisplatin arm, 6 (25%) objective responses (ORs) (3 complete, 3 partial) were observed, whereas 3 partial responses were obtained in the 33 carboplatin-treated patient (9%). Analysis of results, according to response to first-line chemotherapy, demonstrated that the patients who progressed were sensitive only to cisplatin second-line treatment (OR: 3/12), with no responders among carboplatin-treated patients (OR: 0/11). All patients were treated on an outpatient basis and therapy-related toxic effects were mild, consisting chiefly of myelosuppression, and more frequent in the carboplatin group. In our opinion, carboplatin 400 mg/m2 per cycle is scarcely effective in patients with refractory or relapsed ovarian cancer pretreated with cisplatin regimens, whereas cisplatin 100 mg/m2 per cycle appears to be an effective salvage therapy even in patients not responding to carboplatin. The dose of carboplatin should be further escalated especially in refractory patients.

Carboplatin↗

Ultrasound examination in ovarian cancer patients. A comparison with second look laparotomy.

A series of 129 patients with International Federation of Gynecology and Obstetrics (FIGO) stage III-IV ovarian cancer, were evaluated with ultrasound examination and second look surgery. Results of both modalities were correlated in order to assess the reliability of ultrasound in detecting residual disease. After six cycles of chemotherapy, ultrasound was negative in 94 patients and positive in 35 patients. At second look, 57 patients were in complete pathologic remission, 16 had microscopic residual disease, 23 had macroscopic disease less than 2 cm, and 33 had macroscopic disease greater than 2 cm. Correlating ultrasonography and laparotomy, high correlations were seen in patients with no residual disease (92.2%); on the other hand, ultrasound examinations exhibited poor sensitivity and specificity in patients with microscopic disease (6.2%) and residual disease less than 2 cm (8.6%). Using ultrasound discrimination among patients with no residual disease, microscopic disease, or macroscopic disease less than 2 cm does not appear possible. Our suggestion is that ultrasound is not able to replace second look laparotomy in the detection of minimal residual disease in ovarian cancer patients.

Antineoplastic Combined Chemotherapy Protocols↗