Multicentre cross-over study of aminoglutethimide and trilostane in advanced postmenopausal breast cancer.

Trilostane and aminoglutethimide, both given with a physiological replacement dose of hydrocortisone, were randomly allocated to 112 eligible patients with postmenopausal advanced breast cancer. Following treatment failure on either drug the patient continued with the other, if they were in a suitable clinical condition. Sixty-three patients initially received trilostane, of whom 33 subsequently received aminoglutethimide; 49 patients initially had aminoglutethimide and 14 of these then received trilostane. Both groups of patients were comparable in all respects. There was no difference in the response rate to either drug or in the average time to disease progression for the two drugs. Of the 47 patients who received both drugs, nine (19%) showed a response to both, indicating no cross-resistance. Side effects were seen to both drugs in approximately half the patients; these were mainly gastrointestinal symptoms with trilostane and rashes and drowsiness with aminoglutethimide. There was no evidence of cross-over patient susceptibility to side effects.

Multicentre cross over study of aminoglutethimide and trilostane in advanced postmenopausal breast cancer.

Trilostane and Aminoglutethimide, each given with a physiological replacement dose of hydrocortisone, were randomly allocated to 72 eligible postmenopausal advanced breast cancer patients; following treatment failure on either drug the patient continued with the other drug, if in a suitable clinical condition. Thirty-eight patients initially received Trilostane of whom 19 subsequently received Aminoglutethimide; 34 patients initially had Aminoglutethimide and seven of these then received Trilostane. Both groups of patients were comparable in all respects. There was no difference in the objective response rate to either drug, Trilostane 11/38 = 29%, Aminoglutethimide 12/34 = 35%, nor in the average time to disease progression for the two drugs, Trilostane 64 weeks, Aminoglutethimide 68 weeks. Of the 26 patients who received both drugs, four showed a response to both suggesting no cross resistance. Side effects were seen to both drugs in approximately half of the patients, but were mainly gastro-intestinal with Trilostane and rash and drowsiness with Aminoglutethimide. There was no evidence of cross over patient susceptibility to side effects.

Qualitative studies on alpha-interferon-2b in prolonged continuous infusion regimes using gradient elution high-performance liquid chromatography.

The treatment of home-based cancer patients with continuous infusion chemotherapy requires that complete courses of medication in pre-filled syringes are provided on an out-patient basis. The infusion must remain stable prior to use during refrigerated storage (up to 14 days) and during infusion from holster-worn ambulatory infusion pumps where the temperature of the infusion can reach 37 degrees C. In this study, polypropylene syringes containing interferon alpha-2b infusion (3 mega units in 6 ml) were stored at 4 degrees C. The infusion was analysed during storage by a qualitative gradient-elution high-performance liquid chromatography procedure. Over 14 days storage at 4 degrees C or 24 h storage at 37 degrees C, chromatographic changes occurred indicating interconversion between interferon monomers and possibly oligomer formation. Until further studies are completed we consider interferon alpha-2b unsuitable for inclusion in our home oncology programme.

The stability of carboplatin in ambulatory continuous infusion regimes.

Several anti-cancer agents are administered by continuous infusion in an attempt to improve the therapeutic index obtained with solid tumours. In Exeter this approach, combined with the use of ambulatory infusion pumps, forms the basis of a home oncology programme in which a complete course of medication in pre-filled syringes is supplied on an out-patient basis. It is essential to ensure that the drug remains stable during storage prior to use and also during infusion where the temperature of the drug solution in a holster-worn ambulatory pump can reach 37 degrees C. In this study the stability of a carboplatin infusion (20 mg in 2 ml) in pre-filled syringes under storage and in-use conditions was determined using a stability-indicating HPLC assay. There was no loss of carboplatin from pre-filled syringes stored at 4 degrees C for 5 days. At 37 degrees C, the loss of carboplatin was 3.1% over 24 h.

Intracavitary irradiation in palliation of carcinoma of oesophagus and cardia.

Palliative treatment by intracavitary irradiation using the 'Selectron' has been used in 40 patients with advanced carcinoma (all histological types). Relief of dysphagia occurred in 65%. This treatment method is suggested as an effective alternative to intubation.

Half body radiation in plasma cell myeloma.

Sequential hemi-body irradiation can achieve useful responses in the treatment of myeloma. It is less toxic than many widely used drugs and its use in multimodality treatment schedules deserves further attention. The ideal fractionation has also to be determined.

Half-body irradiation in the treatment of metastatic prostatic carcinoma.

High dose radiation therapy given as a single fraction to the upper and lower halves of the body gives effective palliation for metastatic solid tumours. This treatment modality appears to be particularly effective in tumours which may have a slow doubling time such as carcinoma of the prostate. Fifty-two patients with metastatic carcinoma of the prostate involving the skeletal system have received half-body irradiation. All had prior treatment with additive hormones or orchiectomy and the majority had received localised irradiation and/or chemotherapy. Significant immediate pain relief was achieved in 42 out of 52 patients (80%). This pain relief was maintained until death in 29 out of 43 patients (67%). Pain relief in responders appears to occur within 24 to 48 h of treatment.

Single fraction half body radiation therapy.

High-dose radiation therapy given as a single fraction to upper and lower halves of the body provides extremely effective palliation of widespread malignant disease. The side effects are tolerable to patients and the problem of numerous hospital attendances for palliative therapy is avoided. In view of its good tolerance and the theoretical tumour cell kill that may be achieved by this treatment its use in radical treatment should be considered.