Platinum/taxane combinations are widely used in patients with carcinoma of unknown primary (CUP), yielding response rates of 30% and median overall survival of 9 -11 months in selected patients. Yet these combinations have not been subject to a randomised trial to overcome selection bias, a major problem in CUP. We randomised 92 patients to either paclitaxel/carboplatin (arm A) or the non-platinum non-taxane regimen gemcitabine/vinorelbine (arm B). The primary endpoint was rate of practicability as defined: application of X2 cycles of therapy (1) with a maximal delay of 1 week (2) and survival of X8 months (3). Practicability was shown in 52.4% (95% CI 36 -68%) in arm A and in 42.2% (95% CI 28 -58%) in arm B, respectively. The median overall survival, 1-year survival -rate and response rate of patients treated in arm A was 11.0 months, 38, and 23.8%, arm B 7.0 months, 29, and 20%. In conclusion, the paclitaxel/carboplatin regimen showed clinically meaningful activity in this randomised trial (Clinical trial registration number 219, 'Deutsches KrebsStudienRegister', German Cancer Society.)
Myelodysplastic syndrome and acute myelogenous leukemia secondary to radiotherapy, radiation exposure, and chemotherapy is a well-documented malignant stem cell disorder. The incidence and natural course of myelodysplastic syndrome and acute myelogenous leukemia after organ transplantation remains less thoroughly investigated. In our institution, 631 heart transplantations have been performed between 1983 and 1998. We report five patients (age, 22-63 years) with myelodysplastic syndrome (MDS) (n=1) or acute myelogenous leukemia (AML) (n=4) occuring 4-8 years after transplantation. Immunosuppression consisted uniformly of a combination of prednisone, cyclosporine, and azathioprine. Successful cytogenetic analysis was performed in three patients, showing typical cytogenetic abnormalities in each case. The course of AML was uniformly fatal. One patient with MDS, refractory anemia with excess of blasts according to the FAB criteria, is alive with transfusion dependency 32 months after diagnosis. MDS and AML may occur during immunosuppression after heart transplantation. Treatment results are poor in this subgroup of patients with secondary leukemia.
This trial failed to show a benefit for up-front tandem HDCT compared with standard combination therapy. HDCT was associated with more acute adverse effects.
scite is a Brooklyn-based organization that helps researchers better discover and understand research articles through Smart Citations–citations that display the context of the citation and describe whether the article provides supporting or contrasting evidence. scite is used by students and researchers from around the world and is funded in part by the National Science Foundation and the National Institute on Drug Abuse of the National Institutes of Health.