Summary:DCEP (dexamethasone, cyclophosphamide, etoposide, and cisplatin) has proved to be an effective salvage therapy for refractory-relapsed MM patients. Little is known, however, about its potential as mobilizing therapy. The aim of this study was to evaluate the efficacy of DCEP in mobilizing PBSC and to define its toxicity. Fifty-five MM patients received DCEP followed by G-CSF as part of high-dose programs including autologous transplantation. At the time of mobilization, 40 patients had previously received VAD only, and 15 alkylating agents. Mobilization was successful (minimum number of CD34 + cells 2 ؋ 10 6 /kg) in 48/55 patients (87%), and 41/55 patients (75%) collected Ͼ4 ؋ 10 6 /kg CD34 + cells. Of the seven patients who did not mobilize stem cells, five (71%) had been previously exposed to alkylating agents. The median number of CD34 + cells harvested was 5.8 ؋ 10 6 /kg (range 2.1-22.4). There was no treatment-related mortality. The sideeffects of DCEP were always tolerable. No neutropenia Ͻ1000/ l nor thrombocytopenia Ͻ50 000/ l were observed. No patient required transfusion as a consequence of therapy, or hospitalization for septic complications. In conclusion, DCEP, in addition to its demonstrated anti-tumor activity, is an effective regimen for mobilizing peripheral blood progenitor cells in myeloma patients, with little or no side-effects. These properties render DCEP a useful regimen for the debulking and mobilization phase of high-dose pro-
e20726 Background: In patients with cancer who are undergoing to high-dose chemotherapy (HDC), even minimal elevation of TnI is associated with late left ventricular dysfunction. A TnI increase soon after HDC is a strong predictor of poor cardiological outcome. BNP elevation seems to have same prognostic value. Patients treated by standard Anthracycline-based chemotherapy (ADM-CT) doses could not have benefit from TnI/BNP evaluation; on the contrary the method could adsorb too much resources and may not be rational. Methods: To evaluate cardio toxicity trend we studied TnI and BNP in plasma samples of 28 breast cancer pts (female, adjuvant setting, mean age 50), treated with ADM-CT. The samples were detected before (a) one hour (b) and ten days (c) after each course. TnI was considered positive for values ≥ 0.044 ng/mL; BNP for values ≥ 100pg/mL .Comparison between TnI and BNP values were made with the ANOVA method. A probability value < 0.05 was considered statistically significant. Each patient was followed also with LVEF (basal & 3 months after). Results: At present we observed 135 events, mean TnI: (a) 0,00672, (b) 0,006512, (c) 0,005791; BNP (a) 33.8, (b) 36.4, (c) 35.2. We performed 405 detections for both tests; costs: 8.707$ BNP, 10.327$ TnI. No significant difference in test values has been observed between the different time periods. We can't indicate a trend referring to therapy or a particular time period. No patients had LVEF variation. Conclusions: TnI and BNP release pattern after ADM-CT doesn't identify patients at different risk of cardiac events. The program appears useful for HDC treatments, while in normal chemotherapy the data are ongoing and expensive. No significant financial relationships to disclose.
e18190 Background: When ASCO published Top Five List to improve cancer care in 2012, we applied the same principles to build local guidelines, resulting in first edition of our “Libro Blu” (Blue Book), named after a similar tool previously adopted by the Swiss institution IOSI. In 2015 a reform of Lombardy public health, with the establishment of ASST-VAL, covering a huge area with 5 hospitals, brought a further need for harmonization of our work; moreover, the increasing appearance of high cost drugs and the simultaneous restrictions in public health budget required a more rational expense. Methods: After first edition in 2012, Libro Blu underwent periodic updates. In 2015 a major revision took place; besides up-to-date guidelines in the management of specific cancers, edited by Oncology, Hematology and Radiation Therapy specialists, attention was paid to supportive care, with consultants from many other fields. All recommendations in Libro Blu derive from Italian and international guidelines, adapted to our local reality after multidisciplinary discussion, and have been approved after a final joint review. Results: The implementation of Libro Blu resulted in a more consistent application of treatment protocols in ASST-VAL, ensuring all patients the same standard of care, and allowed to raise the level of both specific cancer treatment and supportive care. Furthermore, guidelines for a rational use of drugs allowed to reduce costs in our institution. After one year, 2015 edition of Libro Blu was submitted for review by a number of Italian oncologists from other institutions. Following this review, we used the updated version of Libro Blu to build, with unconditional support from Eli Lilly, a mobile app that will soon be available for download. Conclusions: Libro Blu established a common standard of care in a broad area and allowed a cost reduction that is particularly relevant at this moment, with cancer care facing the appearance of many high cost drugs along with a spending review that involves the Italian health system. The review from other Italian oncologists ensured the adherence of Libro Blu to national guidelines and to state-of-the-art clinical practice. Finally, the mobile app will make consultation easier and will allow to share this tool across all Italian institutions.
High dose therapy represents the gold standard therapy for newly diagnosed multiple myeloma (MM) patients (pts), with no definite agreement about the adoption of single or double transplant. From January 2000 to December 2004, 151 consecutive MM pts aged ≤65 years in stage II, III or I in progression according to Durie-Salmon were enrolled in a multicenter no randomised high dose program including a tandem transplant (Tx1; Tx2). The protocol was designed as follows: 2 pulse-VAD as induction, 2 DCEP to mobilise peripheral blood stem cells (PBSC), double auto-transplant 3-6 months apart each conditioned with high-dose Melphalan at the dose of 200 mg/m2. Patients characteristics at the enrolment: males 76 (51%), females 75 (49%), median age 55 (range: 35–65), stage I in progression 26 (17%), stage II 25 (16%), stage III 100 (67%). Response rates after each phase for the evaluable patients are reported in the table below VAD (151 pts) DCEP (146 pts) Tx1 (119 pts) Tx2 (63 pts) CR (%) 4 9 18 29 VGPR (%) 28 35 48 60 PR (%) 44 30 25 9 SD (%) 18 10 2 0 Progr (%) 6 16 7 0 Patients not addressed to transplant for mobilization failure were only 5%. Most of the patients (75%) collected ≥ 4x106CD34+cells/Kg after each DCEP-cycle which were considered adequate to rescue hemopoiesis after each transplant. The whole protocol was well-tolerated. In particular, no therapy related mortality was associated to pulse-VAD, or DCEP, and no difference between Tx1 and Tx2 as far the transplant related mortality was registered (1.5% after each transplant). Second transplant was not performed in 48 pts for the following reasons: 8 pts (7%) did not collect enough PBSC, 8 pts (7%) have had severe toxicity with the first transplant; 8 pts (7%) underwent allo-TMO; 7 pts (6%) had progressive disease and 15 pts (12%) refused Tx2. Finally only 76 pts (50% of the enrolled pts) completed the program with the second transplant. Analysing data on an intention-to-treat basis, median follow-up was 30 months, median Progression Free Survival (PFS) was 31 months, median overall survival (OS) was not reached. The median Event Free Survival (calculated from the completion of Tx1 to progression or any other event) was 20 months. No difference in terms of PFS and EFS was found comparing pts who finally received only Tx1, with those who completed the protocol (p=0.9; p=0.5). The EFS was not statistically different for patients receiving one or two transplant even when the analysis was performed according to the type of response achieved after Tx1. In conclusion, despite higher percentage of good quality responses (CR+VGPR) can be obtained with 2 transplants with respect to 1 (66% vs 89%) without additional toxicity, no difference in terms of PFS or EFS were observed between the patients who underwent 1 or 2 transplants. Thus, keeping into account the more complex management of patients in a tandem transplant program, it might be more advantageous to perform as initial therapeutic approach, high-dose protocol including only 1 transplant procedure.
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