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The quality of the information provided in post-transplant follow-up is necessary to obtain a coherent and exploitable database. Since the beginning of 2017, three forms (Med-B-allograft) have been available: the first month (Day 0), Day 100 (second report) and an annual follow-up report. Recommendations for follow-up were addressed in the 2014 harmonization workshop, "Harmonization of Data Coding…". However, it is sometimes difficult to determine which data to specify in ProMISe for post-transplantation. The objective of this workshop was to clarify certain situations and/or items.

Purpose To assess the efficacy and toxicity of bortezomib (Velcade; Milennium Pharmaceuticals Inc, Cambridge, MA; formerly PS-341) in patients with metastatic renal cell carcinoma (RCC). Patients and Methods Thirty-seven patients with metastatic RCC were treated with bortezomib. The first 25 patients enrolled onto the trial were treated with a dose of 1.5 mg/m2. The dose was decreased to 1.3 mg/m2 for the subsequent 12 patients, because more than 50% of the patients treated at the higher dose required dose reductions. Bortezomib was given by intravenous administration on a twice-weekly schedule for 2 weeks followed by 1 week without treatment until progression or unacceptable toxicity occurred. Twenty-three patients (62%) previously had undergone nephrectomy, and 19 patients (51%) had previously been treated with cytokine therapy. Results Of the 37 assessable patients, the best response was a partial response in four patients (11%; 95% CI, 3% to 25%) and stable disease in 14 patients (38%; 95% CI, 23% to 55%). The four patients with partial response experienced response durations of 8, 8+, 15+, and 20+ months. Grade 2 or 3 sensory neuropathy was present in 10 patients (53%) overall. One patient in the 1.5 mg/m2 group had grade 3 sensory neuropathy; no grade 3 sensory neuropathy was seen in the 1.3 mg/m2 group. Conclusion The results of this trial suggest that bortezomib has an antitumor effect in individual patients with metastatic RCC. The small proportion of patients who achieved a partial response does not support routine use in metastatic RCC. Efforts to identify the molecular profile associated with clinical response or combination therapy with interferon alfa or other novel agents, may be considered.

PurposeTo describe survival in previously treated patients with metastatic renal cell carcinoma (RCC) who are candidates for clinical trials of new agents as second-line therapy.Patients and MethodsThe relationship between pretreatment clinical features and survival was studied in 251 patients with advanced RCC treated during 29 consecutive clinical trials between 1975 and 2002. Clinical features were first examined in univariate analyses, and then a stepwise modeling approach based on Cox regression was used to form a multivariate model.ResultsMedian survival for the 251 patients was 10.2 months and differed according to year of treatment, with patients treated after 1990 showing longer survival. In this group, the median overall survival time was 12.7 months. Because the purpose of this analysis was to establish prognostic factors for present-day clinical trial design, prognostic factor analysis was performed on these patients. Pretreatment features associated with a shorter survival in the multivariate analysis were low Karnofsky performance status, low hemoglobin level, and high corrected serum calcium. These were used as risk factors to categorize patients into three different groups. The median time to death in patients with zero risk factors was 22 months. The median survival in patients with one of these prognostic factors was 11.9 months. Patients with two or three risk factors had a median survival of 5.4 months.ConclusionTreatment with novel agents during a clinical trial is indicated for patients with metastatic RCC after progression to cytokine treatment. Three prognostic factors for predicting survival were used to categorize patients into risk groups. These risk categories can be used in clinical trial design and interpretation.

BACKGROUND The objective of the current study was to evaluate the effect on response assessment classification in patients with metastatic renal cell carcinoma (RCC) using unidimensional (Response Evaluation Criteria in Solid Tumors) and bidimensional (World Health Organization) criteria, including or excluding measurements of the primary renal tumor and using a new index to compensate for the disproportionate effect of large renal tumors relative to their metastases. METHODS Fifty-three imaging studies involving a total of 44 patients with metastatic RCC who were treated on clinical trials of interferon-α analogue and/or thalidomide were reviewed retrospectively. The best overall response assessment and progression free survival were calculated with both unidimensional and bidimensional tumor measurements. Patients were then stratified into two groups: patients with primary renal tumors in situ and patients who underwent resection of their primary renal tumors. The best overall response and the time to disease progression were calculated based on the sum of measurements (conventional methodology), both including and excluding the primary tumor. A new method of response assessment, the ‘normalized lesion index’, which equalizes the differences in tumor size for an individual patient, was evaluated and compared with the conventional response assessment. RESULTS There was an 11% disagreement rate in the best overall response assessment between unidimensional and bidimensional measurements. The time to progression was 9.2 months measured unidimensionally, compared with 6.4 months assessed bidimensionally. In the group of patients who had primary renal tumors in situ, using the conventional sum of measurements method, the apparent time to progression was an average of 4.2 months longer compared with measurements that did not include the primary renal tumor. The use of the normalized lesion index method resulted in an improved concordance in best overall response assessments and similar time to progression assessments when the primary renal tumor was included compared with patients who did not have primary renal tumors in situ. CONCLUSIONS The use of unidimensional measurements in RCC therapy assessment results in significantly different time to progression classification compared with the use of bidimensional measurements. Response assessment classification in patients with RCC is affected by the exclusion or inclusion of measurements of the primary renal tumor. The normalized lesion index warrants further study in assessing response in patients with metastatic RCC and other solid tumor malignancies that often show substantial differences in sizes of measurable lesions. Cancer 2003. © 2003 American Cancer Society. DOI 10.1002/cncr.11712

Fourteen patients with cisplatin-refractory germ cell tumors (GCT) were treated with temozolomide on a phase II trial. Temozolomide was given orally at 150 mg/m2/day on days 1-5. The cycle length was 28 days. No patient experienced a grade 3 or 4 toxicity, and none of the 14 evaluable patients achieved a complete or partial response. Temozolomide is not efficacious in the treatment of cisplatin-refractory GCT patients.

Purpose To define the incidence, clinical features, and outcome to salvage chemotherapy in patients with late-relapse germ cell tumor (GCT) after a complete response to first-line chemotherapy. Patients and Methods Two patient populations were examined. First, retrospective analysis of 246 patients treated on a clinical trial with salvage chemotherapy was performed; 29 patients with late-relapse GCT were identified and evaluated for treatment outcome and survival. Salvage regimens included paclitaxel, ifosfamide, and cisplatin, single agents, or a high-dose chemotherapy program. Second, the incidence of late relapse was assessed by retrospective analysis of 551 patients after a complete response (CR) to first-line chemotherapy. Results Twenty-nine patients received salvage chemotherapy on a clinical trial for late relapse GCT. The median survival was 23.9 months. At a median follow-up of 50.6 months, there were nine survivors. The chemotherapy regimens varied, but the only CRs were observed in patients treated with paclitaxel, ifosfamide, and cisplatin. Seven (50%) of 14 patients treated with paclitaxel, ifosfamide, and cisplatin achieved a continuous CR. Among the second population of 551 patients who had previously achieved a CR to a first-line chemotherapy trial, 17 were identified as having a late relapse (3%). The median time to relapse for these 17 patients was 7.8 years. Conclusion Late-relapse GCT is uncommon and is associated with a poor prognosis resulting from a high degree of resistance to chemotherapy. Chemotherapy with paclitaxel, ifosfamide, and cisplatin followed by surgery may be effective in patients with late-relapse GCT who are not considered candidates for primary surgery.

Purpose The efficacy of paclitaxel was evaluated in combination with ifosfamide and cisplatin as second-line chemotherapy for patients with relapsed testicular germ cell tumors (GCTs). Patients and Methods Forty-six patients with progressive metastatic GCTs were treated with paclitaxel and ifosfamide plus cisplatin (TIP) as second-line therapy. Eligibility required that patients have both a testis primary tumor site and a prior complete response (CR) to a first-line chemotherapy program, which had been identified previously as favorable prognostic factors to conventional-dose salvage chemotherapy. Results Thirty-two (70%) of 46 patients achieved a CR to treatment. Three patients (7%) who achieved a CR relapsed after TIP chemotherapy. Twenty-nine patients are continuously disease free at a median follow-up time of 69 months, resulting in a 63% durable CR rate and a 2-year progression-free survival rate of 65% (95% CI, 51% to 79%). Conclusion Four cycles of TIP as second-line therapy achieved a durable CR rate in a high proportion of patients with relapsed testicular GCT. The high CR rate emphasizes the importance of patient selection according to prognostic factors to achieve a favorable outcome to conventional-dose salvage therapy.

4522 Background: Late relapse GCT occurs > 2 years after initial chemotherapy and is associated with a poor prognosis (JCO 13:1170). The MSKCC experience with late relapse GCT was examined from two...