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Öğe Addition of Thalidomide (T) to Oral Melphalan/Prednisone (MP) in Patients with Multiple Myeloma: Initial Results of a Randomized Trial From the Turkish Myeloma Study Group.(Amer Soc Hematology, 2009) Beksac, Meral; Haznedar, Rauf; Firatli-Tuglular, Tulin; Ozdogu, Hakan; Aydogdu, Ismet; Konuk, Nahide; Sucak, Gulsan[Abstract Not Available]Öğe Addition of thalidomide to oral melphalan/prednisone in patients with multiple myeloma not eligible for transplantation: results of a randomized trial from the Turkish Myeloma Study Group(Wiley, 2011) Beksac, Meral; Haznedar, Rauf; Firatli-Tuglular, Tulin; Ozdogu, Hakan; Aydogdu, Ismet; Konuk, Nahide; Sucak, GulsanThe combination of melphalan-prednisone-thalidomide (MPT) has been investigated in several clinical studies that differed significantly with regard to patient characteristics and treatment schedules. This prospective trial differs from previous melphalan-prednisone (MP) vs. MPT trials by treatment dosing, duration, routine anticoagulation, and permission for a crossover. Newly diagnosed patients with multiple myeloma (MM) (n = 122) aged greater than 55 yr, not eligible for transplantation were randomized to receive 8 cycles of M (9 mg/m2/d) and P (60 mg/m2/d) for 4 d every 6 wk (n = 62) or MP and thalidomide (100 mg/d) continuously (n = 60). Primary endpoint was treatment response and toxicities following 4 and 8 cycles of therapy. Secondary endpoints were disease-free (DFS) and overall survival (OS). Overall, MPT-treated patients were younger (median 69 yr vs. 72 yr; P = 0.016) and had a higher incidence of renal impairment (RI, 19% vs. 7%, respectively; P = 0.057). After 4 cycles of treatment (n = 115), there were more partial responses or better in the MPT arm than in the MP arm (57.9% vs. 37.5%; P = 0.030). However, DFS and OS were not significantly different between the arms after a median of 23 months follow-up (median OS 26.0 vs. 28.0 months, P = 0.655; DFS 21.0 vs. 14.0 months, P = 0.342, respectively). Crossover to MPT was required in 11 patients, 57% of whom responded to treatment. A higher rate of grade 3-4 infections was observed in the MPT arm compared with the MP arm (22.4% vs. 7.0%; P = 0.033). However, none of these infections were associated with febrile neutropenia. Death within the first 3 months was observed more frequently in the MP arm (n = 8, 14.0%) than in the MPT arm (n = 2, 3.4%; P = 0.053). Long-term discontinuation and dose reduction rates were also analyzed (MPT: 15.5% vs. MP: 5.3%; P = 0.072). Although patients treated with MPT were relatively younger and had more frequent RI, better responses and less early mortality were observed in all age groups despite more frequent discontinuation. This study is registered at http://www.clinicaltrials.gov as #NCT00934154.Öğe The Evaluation of Procalcitonin as a Diagnostic and Prognostic Marker of Bacterial Infections in Febrile Neutropenic Patients(Aves, 2011) Yetkin, Funda; Senol, Esin; Yalcin, Selim; Haznedar, RaufObjective: The aim of this study was to evaluate the role of procalcitonin (PCT) in the diagnosis, prognosis and follow-up of bacterial infections in febrile neutropenic patients in comparison to the standard parameter, C-reactive protein (CRP). Methods: 40 febrile neutropenic episodes of 37 patients with cancer undergoing chemotherapy were classified as fever of unknown origin (FUO), microbiologically or clinically documented infection. Four sequential serum samples were obtained at the onset of neutropenia, on the first and third days of fever and on the day of defervescence, or on day 5 or 7 of an unresolved fever. Results: At the onset of neutropenia, the PCT levels were found to be normal whereas CRP levels were found to be elevated in all patients. With the febrile episode, PCT levels were elevated in all types of infections which were significantly higher for documented infections compared to FUO (p< 0.05). Procalcitonin levels differed significantly between patients with and without severe sepsis (p<0.001), and the highest levels were seen on the third day of fever. PCT levels decreased rapidly in afebrile patients treated successfully, whereas they remained significantly higher for patients unresponsive to therapy (p<0.001). Conclusions: In conclusion, PCT could be suggested as a useful marker, and was superior to CRP for early diagnosis of documented infections, assessment of the severity of infection and response to therapy in febrile neutropenic patients.Öğe Febril nötropenik hastalarda bakteriyel infeksiyonların tanısal ve prognostik bir göstergesi olarak prokalsitoninin değerlendirilmesi(Klimik Dergisi, 2011) Yetkin, Funda; Şenol, Esin; Yalçın, Selim; Haznedar, RaufÖz: Amaç: Maligniteli hastalardaki febril nötropeni ataklarında prokalsitonin (PCT) in bakteriyel infeksiyonların tanısal ve prognostik bir göstergesi olarak standard bir parametre olan C-reaktif protein (CRP) ile karşılaştırılıp değerlendirilmesi amaçlandı. Yöntemler: Kemoterapiye bağlı 37 hastadaki 40 febril nötropenik atak üç gruba ayrıldı: nedeni bilinmeyen ateş (NBA), mikrobiyolojik olarak tanımlanmış infeksiyon ve klinik olarak tanımlanmış infeksiyon. Nötropeni başlangıcında, ateşin ilk ve üçüncü günü, ateşin düştüğü gün ya da tedaviye yanıtsız hastalarda tedavinin 5-7. günü olmak üzere toplam dört kan örneği alındı. Bulgular: Tüm ataklarda nötropeni başlangıcında PCT düzeyleri normal değerlerde bulunurken, CRP düzeyleri normal değerlerin üzerinde saptandı. Ateşin üçüncü günü PCT deki yüksekliğin tanımlanmış infeksiyonu olan gruplarda, NBA grubuna göre daha fazla olduğu gözlendi (p<0.05). Sepsisi olan ve olmayan gruplarda PCT düzeyleri farklı bulundu (p<0.001) ve en yüksek değerlerine sepsis grubunda ateşin 3. gününde ulaştı. Tedaviye yanıtsız grupta PCT düzeylerindeki artış anlamlı ölçüde sürerken, tedaviye yanıtı olan grupta, ateşin düşmesi ile birlikte hızla normal değerlere geriledi (p<0.001). Sonuçlar: Bu bulgular ışığında, febril nötropenik hastalarda PCT nin, dokümante infeksiyonların erken tanısında, infeksiyonun şiddetini ve tedaviye yanıtı belirlemede yararlı olacağı ve CRP den daha üstün olduğu sonucuna varıldı.
