Eligibility audits for the randomized neuropathic bone pain trial (TROG 96.05).

In February 1996 the Trans-Tasman Radiation Oncology Group (TROG) initiated a two-arm, multicentre, prospective randomized trial on radiotherapy for neuropathic pain due to bone metastases (TROG 96.05). This trial compares the response to a single 8-Gy fraction with 20 Gy in five fractions. The accrual target is 270 patients. In order to evaluate compliance with eligibility criteria after approximately 1 year of accrual, an independent audit of the first 42 randomized patients was commissioned. This found that only one of these patients did not have genuine neuropathic pain, but that this patient and seven others (19%) had infringements of other eligibility/exclusion criteria for the trial. Accordingly it was decided to continue the full audit up to 90 patients. This detected no further patients without genuine neuropathic pain, and found only one other eligibility infringement (1/48; 2%). It is concluded that this quality assurance (QA) measure undertaken early in the trial led to significantly improved clinician awareness of, and compliance with, eligibility/exclusion criteria. It also enabled an accurate comparison of outcome data for all randomized versus all eligible patients at the time of the preplanned first interim analysis at 90 patients. In view of the excellent compliance demonstrated in the second audit, a one-in-five sampling is proposed for future audits from centres that have already accrued at least five consecutive eligible patients. This is consistent with TROG QA guidelines now operational.

Referral patterns for gynaecological radiotherapy in Victoria.

A retrospective chart review was undertaken on all patients in Victoria who were referred for radiotherapy for a gynaecological cancer from February 1997 to January, 1998. Three hundred and ten patients were identified which represents less than one-third of all gynaecological cancers diagnosed in Victoria each year. Ninety-two of the 310 patients (30%) referred for radiotherapy were managed without the prior involvement of a certified gynaecological oncologist. The 310 patients included 95 patients with cervical cancer, 33 patients with ovarian cancer and 142 patients with endometrial cancer. The initial management strategies employed for patients with the major gynaecological cancers varied depending on the source of referral. This difference was most marked in endometrial cancer due mainly to differing indications for full surgical staging and subsequent referral for radiotherapy both between types of specialists and also between gynaecological oncology units. The development of evidence based guidelines in the major gynaecological cancers should lead to a more uniform approach to the care of women with gynaecological malignancies.

A role for radiotherapy in neuropathic bone pain: preliminary response rates from a prospective trial (Trans-tasman radiation oncology group, TROG 96.05)

PURPOSE: Radiotherapy (RT) has a proven role in palliation of pain from bone metastases with numerous randomized trials obtaining response rates (RRs) of typically 70-80% regardless of the fractionation employed. However RT for neuropathic bone pain (NBP), i.e., pain with a radiating cutaneous component due to compression/irritation of nerves by tumor has not previously been studied, and its role is thus uncertain. METHODS AND MATERIALS: In February 1996, the Trans-Tasman Radiation Oncology Group (TROG) initiated a multicenter randomized trial comparing a single 8 Gy fraction with 20 Gy in 5 fractions for NBP with an accrual target of 270. Formal interim analyses were planned at 90 and 180 patients. The 90th patient was accrued in June 1998, and data from the first interim analysis with both arms combined form the basis of this report. RESULTS: Forty-four patients were randomized to a single 8 Gy, 46 to 20 Gy in 5 fractions. The commonest primary sites were prostate (34%), lung (28%) and breast (10%). Median age was 68 years (range 37-89). The index site was spine (86%), rib (13%), base of skull (1%). On an intention-to-treat basis, the overall RR was 53/90 = 59% (95% CI = 48-69%), with 27% achieving a complete response and 32% a partial response. The overall RR for eligible patients was 49/81 = 60% (95% CI = 49-71%) with 27% and 33% achieving complete and partial responses respectively. Estimated median time to treatment failure was 3.2 months (95% CI = 2.1-5.1 months), with estimated median survival of 5.1 months (95% CI = 4.2-7.2 months). To date, six spinal cord/cauda equina compressions and four new or progressive pathological fractures have been detected at the index site after randomization, although one cord compression occurred before radiotherapy was planned to commence. In February 1999, the Independent Data Monitoring Committee strongly recommended continuation of the trial. CONCLUSION: Although these results are preliminary, it seems clear that there is indeed a role for RT in the treatment of NBP. Analysis of outcome by treatment arm awaits completion of the randomized trial.

First reported case of endometrial carcinoma in association with HIV infection.

Endometrial adenocarcinoma is the most common gynecologic cancer in developed countries, although it has never before been documented in a female infected with human immunodeficiency virus (HIV). By contrast, cervical carcinoma is well described in association with HIV infection and in 1993 was added to the AIDS case definition. We present the unique case of a 38-year-old HIV-infected female with endometrial carcinoma, who became rapidly disseminated following her initial surgery. Although HIV is unlikely to have an etiologic role in endometrial carcinoma, it is conceivable that immunosuppression contributed to an accelerated course of her malignancy.