Traditionally, separate prognostic factor analyses were performed for patients undergoing CDCT and HDCT, respectively.
Given the variation in prognostic factors reported in these and other studies, the separate focus on CDCT and HDCT, the limited number of patients from which these models were derived, and the small number of chemotherapy (particularly HDCT) regimens used, a collaborative effort, known as the International Prognostic Factor Study Group (IPFSG), was formed to develop a universally accepted prognostic model prior to initial salvage chemotherapy.
Cisplatin plus ifosfamide-containing regimens form the backbone of salvage CDCT, with studies testing a variety of third drugs to add to this combination.
This trial limited eligibility to patients with features predicting a favorable outcome to salvage CDCT including gonadal primary tumor site and either a CR to first-line chemotherapy or a partial response with negative tumor markers (PR-negative markers) lasting [greater than or equal to] 6 months.
Since 1990, a consistent approach offering single course HDCT as consolidation after response to a full course of CDCT has been used at our institution.
The inclusion criteria of the IPFSG group were strictly observed.[sup.9] To be eligible, patients had to be male with metastatic germ cell tumour defined either by histology and/or unequivocal serum tumour markers with: first-line chemotherapy after 1 January 1990, at least three cycles of cisplatin-based first-line chemotherapy in patients without refractory disease in response to first-line therapy, first-line treatment with etoposide, known response to first-line treatment, no HDCT as first-line treatment, unequivocal relapse or progression after first-line chemotherapy, no previous salvage chemotherapy, and first-salvage treatment with either cisplatin-based CDCT chemotherapy or carboplatin-based HDCT.
Men with metastatic germ cell tumour at first salvage were treated with CDCT consisting of ifosfamide 1200 mg/m[sup.2] intravenous on days 1 to 5, cisplatin 100 mg/m[sup.2] on days 1 to 5, and etoposide 75 to 100 mg/m[sup.2] intravenous on days 1 to 5 (VIP) repeated every 21 days for up to four cycles with standard dose reductions.[sup.13] A few patients received vinblastine 0.11 mg/kg on days1 to 2 instead of etoposide (VeIP).[sup.14] Treatment was given at the hospital to insure adequate hydration and mesna administration.
All eligible patients were classified into "very low," "low," "intermediate," "high" and "very high" risk categories using the IPFSG criteria, and then further classified by whether they received CDCT alone or followed by HDCT.
Most of the members of the CDCT agreed that narrower roads with traffic calming will regulate traffic better than a wider and unimpeded road, providing safe passage for pedestrians, bicyclists and drivers alike.
So do we - not necessarily that he had thanked his neighbors for their work, but that he had attended our meetings, studied the process notes and designs posted on the Web site, walked the route with a CDCT member, even talked to his students about this ongoing example of community involvement in our midst.
Retrospective comparisons of HDCT versus CDCT alone as first-line therapy for relapsed GCT are limited by several considerations: physicians may identify healthier patients who are able to tolerate HDCT compared with CDCT alone; the CDCT comparator group includes patients who were planned to receive HDCT after initial tumour debulking with CDCT, but never received HDCT because of toxicity or an inadequate therapeutic response; and the observed differences may be due to improvements in supportive care and surgical techniques for resection of residual masses that coincide with a greater proportion of patients receiving upfront HDCT compared with CDCT alone over time.
These unanswered questions include: the optimal number of cycles of HDCT (one, two and three cycles have been used by different groups) with autologous stem cell support; if relapsing patients should proceed directly to HDCT upon diagnosis of relapse or if they should initially be treated with one to three cycles of induction CDCT to stabilize their disease and allow time to coordinate HDCT with autologous stem cell support with the transplant team; and if there are certain groups of patients with relapsed disease, such as patients with primary mediastinal non-seminoma or late (>2 years) relapse that cannot be resected surgically, whose outcome is so poor that they should not be considered candidates for HDCT.