From May 1984 through December 1986, 141 patients with metastatic adenocarcinoma of the colon or rectum were entered on this Hoosier Oncology Group (HOG) trial evaluating the role of cisplatin in systemic therapy. Patients were stratified by the presence or absence of hepatic metastases and by performance status, and were subsequently randomized to receive fluorouracil (5-FU) (15 mg/kg/wk) alone or the same dose of 5-FU plus cisplatin (60 mg/m2 every 3 weeks). The total duration of treatment was six cycles (18 weeks). In 132 fully evaluable patients the objective response rates were 19% for 5-FU and 22% for 5-FU plus cisplatin. Statistically, the median survival times of 40 and 39 weeks were not significantly different (P = .62). However, the median duration of remission (MDR) was superior (P = .05) for 5-FU alone. This study fails to confirm clinically significant synergy of 5-FU plus cisplatin in the treatment of metastatic colorectal cancer.
In this phase III randomized study, 124 evaluable patients with unresectable non-small-cell lung cancer (NSCLC) were randomized to vindesine v cisplatin (120 mg/m2) plus vindesine v cisplatin (60 mg/m2) plus vindesine plus mitomycin C. The objective response rate for cisplatin and vindesine was 27% v 20% for cisplatin, vindesine, and mitomycin C, and 14% for vindesine alone (P = .25 for cisplatin and vindesine v vindesine). The percentage of patients having stable disease (no progression for a minimum of 3 months) was 20% (cisplatin and vindesine), 27% (cisplatin, vindesine, and mitomycin C), and 26% (vindesine alone), respectively. The median survival time for vindesine was 18 weeks, compared with 26 weeks for cisplatin and vindesine and 17 weeks for cisplatin, vindesine, and mitomycin C. Overall survival was not statistically different for cisplatin plus vindesine v vindesine (P = .65). There was no evidence for improved duration of remission or survival of responders with the cisplatin (120 mg/m2) and vindesine arm. This study failed to demonstrate sufficient therapeutic benefit for cisplatin and vindesine (+/- mitomycin C) compared with single-agent vindesine to justify the increased cost and toxicity of these combination regimens.
Object. The authors report their early results from an ongoing experience treating patients with choroidal melanoma by using gamma knife radiosurgery (GKS).
Methods. Between September 1998 and March 2000, 11 patients were treated for choroidal melanoma. Treatment was facilitated with specialized frame placement. Eye immobilization was accomplished with supra- and infraorbital nerve block and tethering sutures to the periorbital tissue. Magnetic resonance imaging was performed to localize the tumor for treatment planning. Plugging patterns were used to steer fall-off radiation away from the fovea, optic nerve, or lens. Tumor volume, tumor location relative to critical structures, and dose to critical structures were determined using GammaPlan. Tumor response was determined using ultrasonography. Toxicity was determined by clinical assessment, visual acuity testing, and ophthalmoscopy.
All 11 patients successfully completed the treatment. In every case, 40 Gy was prescribed to the 50% isodose, which completely encompassed all visible tumor. Tumor height ranged from 2.9 to 7 mm. The tumor diameter ranged from 6 to 13 mm. The range of follow up was 2 to 19 months. No tumor has progressed. One patient had improvement in vision because of improvement in retinal detachment. Two patients experienced visual decline. One patient's visual decline was due to a vitreous hemorrhage, and the other's was due to hard exudates encroaching on the macula. One patient has developed a dry eye that is managed effectively with topical eye lubricants.
Conclusions. This preliminary experience demonstrates that GKS is a feasible treatment option for small- to medium-sized choroidal melanomas. Longer follow up and additional patients will be required to improve the assessment and the ultimate tumor control and toxicity in this ongoing series.
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