Cetuximab plus irinotecan in pretreated metastatic colorectal cancer patients: the ELSIE study.

AIM: To evaluate the efficacy and safety of cetuximab plus irinotecan in irinotecan-refractory metastatic colorectal cancer (mCRC) patients from South-East Asia and Australia. METHODS: In this open-label, phase II study, the main eligibility criteria were epidermal growth factor receptor-positive mCRC with progressive disease within 3 mo of an irinotecan-based regimen as the most recent chemotherapy. Patients received cetuximab 400 mg/m2 initially, then 250 mg/m2 every week, with the same regimen of irinotecan on which the patients had progressed (4 pre-defined regimens allowed). The primary objective was evaluation of progression-free survival (PFS) at 12 wk. Secondary objectives included a further investigation of PFS, and an assessment of the overall response rate (ORR), duration of response, time to treatment failure (TTF), overall survival and the safety profile. RESULTS: One hundred and twenty nine patients were enrolled from 25 centers in the Asia-Pacific region and of these 123 received cetuximab plus irinotecan. The most common recent irinotecan regimen used was 180 mg/m2 every 2 wk which had been used in 93 patients (75.6%). The PFS rate at 12 wk was 50% (95% confidence interval (CI, 41-59) and median PFS time was 12.1 wk (95% CI: 9.7-17.7). The ORR was 13.8% (95% CI: 8.3-21.2) and disease control rate was 49.6% (95% CI: 40.5-58.8). Median duration of response was 31.1 wk (95% CI: 18.0-42.6) and median overall survival was 9.5 mo (95% CI, 7.5-11.7). The median TTF was 11.7 wk (95% CI: 9.1-17.4). Treatment was generally well tolerated. The most common grade 3/4 adverse events were diarrhea (13.8%), neutropenia (8.9%), rash (5.7%) and vomiting (5.7%). CONCLUSION: In patients from Asia and Australia, this study confirms the activity and safety of cetuximab plus irinotecan observed in previous studies in Europe and South America.

Comparison of ramosetron and granisetron for the prevention of acute and delayed emesis in Cisplatin-based chemotherapy: a randomized controlled trial.

OBJECTIVE: A clinical study of ramosetron was carried out to evaluate its efficacy in preventing both acute and delayed emesis in cisplatin-based chemotherapy by using a double-blind method with granisetron as the comparative drug. METHODS: Cisplatin at a dose of > or =70 mg/m(2) was administered as a single intravenous (i.v.) infusion over 4 h. Patients were randomly assigned to receive either ramosetron (0.3 mg i.v. bolus 30 min before cisplatin on Day 1 and a 0.1 mg tablet in the morning for Days 2 to 5 after completion of chemotherapy; n = 36) or granisetron (3 mg i.v. infusion 30 min before cisplatin on Day 1 and a 1 mg tablet in the morning for Days 2 to 5 after completion of chemotherapy; n = 37). The observation period started with the initiation of chemotherapy (0 h) and continued for 24 h after completion of the chemotherapy for acute emesis, and on Days 2 to 5 for delayed nausea and vomiting. RESULTS: A total of 73 patients were eligible for evaluation, with 36 patients in the ramosetron group and 37 in the granisetron group. The efficacy of both drugs was analyzed in terms of the degree of achievement in each day of treatment. Ramosetron was as effective as granisetron in preventing nausea and vomiting (both acute and delayed emesis). The two drugs had a similar safety profile and adverse events were generally mild and transient. CONCLUSIONS: Ramosetron is effective and safe for the control of acute and delayed emesis induced by cisplatin.

Cancer incidence in Thailand, 1995-1997.

There are five population-based cancer registries in Thailand in different regions of the country. Four of them (Chiang Mai, Khon Kaen, Bangkok, and Songkhla) have been operating since 1988 and the other (Lampang) since the early 1990s. These registries have published regular 3-year cancer incidence reports since the first in 1993 for the period 1989-1991. The objective of this article is to summarize the figures of cancer incidence in Thailand during 1995-1997. The population of Thailand in 1996, at the middle of the period, was 27 million males and 27.5 million females. Information of cancer cases residing in the five provinces was collected and abstracted from different sources. Age-standardized incidence rate (ASR) of cancer in males and females was calculated for each registry and that for the whole country was estimated using the five registries as representatives for the four geographical regions of Thailand. The estimated number of new cancer cases in 1996 for the whole country was 35,539 men and 38,476 women and the ASRs were 149.2 and 125.0 per 10(5) population in men and women respectively. Cancer incidences greatly differed from region to region. Lung cancer was the commonest in Chiang Mai and Lampang in the Northern region in both sexes. The incidence of liver cancer in Khon Kaen in the Northeastern region outnumbered all the others in both sexes; cholangiocarcinoma was the major type of liver cancer. In Bangkok, lung cancer was the most important cancer in males and breast cancer was in females. Though it was lung and cervix uteri cancer that ranked the first in men and women in Songkhla, the rate of oral and pharyngeal cancer was exceptionally higher than in other registries. The geographical variability in cancer patterns in Thailand reflects exposure of the population to different risk factors unique to the different regions. In the study as a whole, there are some methodological weak points in estimating the ASRs and number of cancer cases for the whole country, but the results are the most reliable cancer statistics from Thailand at the moment. In conclusion, both a country-wide and region-specific cancer control programmes are needed for Thailand. The national one would be for the cancers common to all regions, and the provincial-level emphasis should be on cancers which are the major problems in the area.