ABSTRACT
BACKGROUND: To establish the role of antiemetic therapy with neurokinin-1 (NK-1) receptor antagonists (RAs) in Chinese patients associated with cisplatin-base chemotherapy regimens, this study evaluated the efï¬cacy and safety of single-dose intravenous fosaprepitant-based triple antiemetic regimen to a 3-day orally aprepitant-based antiemetic triplet schedule for the prevention of chemotherapy-induced nausea and vomiting (CINV). METHODS: A randomized, double-blind, positive-control design was used to test the noninferiority of fosaprepitant towards aprepitant. Patients receiving cisplatin-base (≥50 mg/m2) chemotherapy were administrated palonosetron and dexamethasone with a single-dose fosaprepitant (150 mg on day 1) or a standard aprepitant regimen (125 mg on day 1, 80 mg on day 2 and day 3). The primary endpoint was complete response (CR) during overall phase (OP). Secondary endpoints include CR during acute phase (AP) and delayed phase (DP), no vomiting and no significant nausea during OP, AP and DP. Accrual of 324 patients per treatment arm was planned to conï¬rm noninferiority with expected CR of 75% and noninferiority margin of minus 10 percentage points. RESULTS: A total of 648 patients were randomly assigned, and 644 were evaluable for efï¬cacy and safety. Antiemetic efficacy of CR during the OP with fosaprepitant and aprepitant was equivalent (71.96% versus 69.35%, P=0.4894). And a between-group difference of 2.61 percentage points was finally achieved (95% CI, -4.42 to 9.64) within predeï¬ned bounds for noninferiority (primary end point achieved). Both regimens were well tolerated and commonly reported adverse events (≥1%) were similar between these two group. CONCLUSIONS: Single-dose intravenous fosaprepitant (150 mg) combined with palonosetron and dexamethasone was well tolerated and demonstrated noninferior control of CINV to aprepitant-based triple regimen in Chinese patients treating with cisplatin-base chemotherapy.
ABSTRACT
OBJECTIVE: To evaluate the curative effect and complication of (252)Cf brachytherapy on cervical cancer. METHODS: From Nov 2002 to Nov 2007, 110 cervical cancer patients were treated by combination of (252)Cf neutron intracavitary brachytherapy and external beam radiotherapy. There were 2 cases of stage Ib, 5 stage IIa, 57 stage IIb, 2 stage IIIa, 41 stage IIIb, 2 stage IVa, and 1 stage IVb. The whole pelvic cavity was irradiated with 8 MV X-ray, 1.8 Gy/fraction, 4 - 5 times per week. The total dose of external beam radiotherapy was 40 - 50 Gy (the center of whole pelvic field was blocked by 4 cm in width after 20 - 30 Gy). (252)Cf neutron intracavitary brachytherapy was delivered at 6 - 8 Gy(i)/fraction, and the total dose of reference point A was 30-51 Gy(i). The median dose was 42 Gy(i). RESULTS: The overall 3-year survival rate of all patients was 79.2%, and the local control rate was 90.0%. In particular, the 3-year survival rate was 1/2 for stage I, 84.3% for stage II, 53.7% for stage III. The difference between stage II and stage III was statistically significant (P < 0.05). The 3-year survival in cervical lesions larger than or equal to 4 cm and those less than 4 cm was 68.1% and 71.2%, respectively (P > 0.05). The 3-year survival rate of patients with and without anemia was 42.4% and 78.2%, respectively (P < 0.05). The 3-year survival rate of patients with squamous cell carcinoma and adenocarcinoma was 78.5% and 76.9%, respectively (P > 0.05). The late radiation complications of rectum and bladder was 11.8% (13/110) and 2.7% (3/110), respectively. CONCLUSION: It is concluded that (252)Cf is a better source for intracavitary brachytherapy. According to our initial experience, (252)Cf has advantages of a high local control rate, especially to bulky tumor and adenocarcinoma.
