Improved Survival in Patients with Peripheral T Cell Lymphoma, Unspecified Following High-Dose Therapy and Stem Cell Transplantation: A Retrospective Review of a Single Institution’s Experience.

Blood ◽  
2006 ◽  
Vol 108 (11) ◽  
pp. 3062-3062
Author(s):  
Ryan A. Wilcox ◽  
Ahmet Dogan ◽  
Kay Ristow ◽  
Joseph P. Colgan ◽  
Thomas M. Habermann ◽  
...  
Keyword(s):  
Overall Survival ◽  
Stem Cell ◽  
Performance Status ◽  
Complete Response ◽  
High Dose ◽  
High Dose Therapy ◽  
Ecog Performance Status ◽  
First Response ◽  
Hodgkin's Lymphomas ◽  
Disease Free

Abstract Background: Peripheral T-cell non-Hodgkin’s lymphomas (PTCL) account for approximately 10% of all non-Hodgkin’s lymphomas in the U.S. and Europe. PTCL, unspecified (PTCL-U), as classified by the WHO, is the most common subtype. The ability of high-dose therapy (HDT) and stem cell transplantation (SCT) to improve patient outcome was evaluated in the current study. Methods: All patients with PTCL-U evaluated at our institution who had tissue specimens available for review from January, 1994 to December, 2005 were identified and both clinical characteristics and treatment course obtained from the medical record. Results: 89 patients with PTCL-U were identified, with a median follow up of 13 months (range 1 month–12 years). The median age at diagnosis was 56 years (range 24–90). The IPI was low, intermediate or high in 34%, 44% and 22% of patients, respectively. On univariate analysis, age >60 (p<.0001), ECOG performance status >1 (p<.0001), LDH greater than normal (p=.004), Ann Arbor Stage III/IV (p=.01) and the presence of B symptoms (p=.0004) were associated with a poorer overall survival, as was an intermediate or high IPI (p<.0001). In contrast, on multivariate analysis only age >60 (p=.0006) and ECOG performance status >1 (p=.007) were independently associated with poorer overall survival. Fifty-seven percent of patients were treated initially with an anthracycline-based regimen, most commonly CHOP (53%). Patients with a low (0–1), intermediate (2–3) or high (4–5) IPI experienced a 61%, 29% and 18% 5-year overall survival, respectively. Fourteen patients (16%) received HDT and autologous (n=12) or allogeneic (n=2) SCT, either at the time of a first partial or complete response (n=11) or at the time of first relapse (n=3). The median survival in those patients treated initially with an anthracycline-based regimen alone was 11 months (95% CI 0.6–1.6 years). Improvement in both 5-year overall (75% vs 24%, HR=5.6, 95% CI 2.0–23.4, p=.0004) and disease-free (60% vs 26%, HR=3.2, 95% CI 1.3–9.3, p=.008) survival was observed in patients who received HDT/SCT, as compared to patients treated with anthracycline-based therapy alone. Furthermore, improvement in both 5-year overall (80% vs 26%, HR=5.8, 95% CI 1.7–35.7, p=.002) and disease free (72% vs 26%, HR=3.8, 95% CI 1.3–15.8, p=.009) survival was observed in patients who received HDT/SCT at the time of a first partial or complete response when compared to patients who received anthracycline-based therapy. When patients who failed to achieve a first partial or complete response were excluded from the analysis, improved 5-year overall (80% vs 57%, HR=0.5, 95% CI 0.1–2.1, p=.4) and disease-free (72% vs 53%, HR=0.7, 95% CI 0.1–2.3, p=.5) survival were observed in patients who received upfront HDT/SCT, although this failed to reach statistical significance. The improved overall and disease free survival observed in patients receiving HDT/SCT, either at the time of a first response or at the time of relapse, remained significant when accounting for differences in the IPI. In conclusion, selected patients with PTCL-U may benefit from treatment with HDT/SCT following a first response to conventional anthracycline-based chemotherapy.

Rituximab® and High Dose Methylprednisolone (HDMP) for the Treatment of Patients with Relapsed/Refractory Chronic Lymphocytic Leukemia.

Blood ◽  
2004 ◽  
Vol 104 (11) ◽  
pp. 2518-2518
Author(s):  
Januario E. Castro ◽  
Jan Bole ◽  
Carlos E. Prada ◽  
Thomas J. Kipps
Keyword(s):  
Chronic Lymphocytic Leukemia ◽  
Performance Status ◽  
Variable Region ◽  
Response Assessment ◽  
Complete Response ◽  
Lymphocytic Leukemia ◽  
High Dose ◽  
Ecog Performance Status ◽  
Female Ratio ◽  
High Dose Methylprednisolone

Abstract High-dose gluocorticoids and the anti-CD20 mAb Rituximab each can effect partial responses in patients with chronic lymphocytic leukemia (CLL), although complete and durable responses to treatment with either of these agents have not been reported. We examined whether patients with relapsed and/or refractory CLL could respond to these agents when used in combination in a pilot clinical trial. Fourteen patients with progressive, symptomatic, and relapsed/refractory disease were treated with three four-week cycles of high-dose Methylprednisolone (HDMP) at 1gr/m2 daily for 5 days and weekly Rituximab® at 375mg/m2 for four weeks. The median age of the patients was 60 years, the male to female ratio was 4:1, the ECOG performance status was &lt; 2, and the average number of prior treatments was 2. All patients failed or were intolerant to fludarabine and 86% had high-risk disease by the modified Rai classification. Sixty-five percent of the patients had CLL cells that expressed ZAP-70 and unmutated immunoglobulin variable region genes. Response assessment was performed at the end of each cycle, two months after completion of treatment, and each 3–6 months thereafter until the patients experienced disease progression and/or required further treatment. Objective responses were observed in all 14 patients, with 6 patients achieving a complete response (CR) and the remainder a partial response (PR) as per the NCI-working group criteria. We observed a significant decrease in peripheral white blood cell (WBC) counts, increase in hemoglobin, elevation of platelet counts and a dramatic decrease in lymphadenopathy and splenomegaly. Five of the treated patients have not required further treatment with a median follow up of 26 months. Of these 5 patients 3 have maintain a CR. The median time to progression (TTP) was 12 months. Overall, the treatment was well tolerated and all the patients, except one, completed 3 cycles of therapy. The majority of adverse events were Grade I-II (fluid retention, cough, transient hyperglycemia, fatigue). In addition, we observed 7 episodes of grade III-IV toxicity secondary to (anemia, CMV esophagitis and GI bleeding with one case each and two cases each of thrombocytopenia and neutropenia). These data suggest that treatment with the combination of Rituximab® and HDMP has increased activity over treatment with either agent alone and may produce durable complete responses in patients with refractory and / or relapsed CLL.

Autologous Transplant Event-Free Survival (EFS) Following Failure of CHOP-Rituximab (CHOP-R) for Diffuse Large B-Cell Lymphoma (DLBCL) Is the Same as the EFS Following Failure of CHOP Alone.

Blood ◽  
2004 ◽  
Vol 104 (11) ◽  
pp. 890-890 ◽  
Author(s):  
Julie M. Vose ◽  
Philip J. Bierman ◽  
James C. Lynch ◽  
Gregory Bociek ◽  
James O. Armitage
Keyword(s):  
Overall Survival ◽  
Stem Cell ◽  
Stem Cell Transplantation ◽  
Cell Transplantation ◽  
Autologous Stem Cell Transplantation ◽  
Chemotherapy Resistance ◽  
B Cell Lymphoma ◽  
Complete Response ◽  
High Dose Chemotherapy ◽  
High Dose

Abstract Several studies have now identified that the addition of rituximab (R) to CHOP chemotherapy has increased the complete response, EFS, and overall survival (OS) for patients with previously untreated DLBCL. However, concerns of increased resistance of DLBCL following failure of CHOP-R and the inability to salvage those patients with high-dose chemotherapy and autologous stem cell transplantation have been raised. In an attempt to address this issue, we evaluated 103 patients with high risk, relapsed, or refractory DLBCL receiving high-dose chemotherapy and autologous stem cell transplantation at our center between 1999 and 2003. Fifty-six (54%) of the patients received CHOP as their initial induction therapy and 47 (46%) received CHOP-R. The patients ranged in age from 20–73 years (median 50). Sixty patients were male and 43 female. Sixty two of the patients were transplanted < 12 months from diagnosis and 41 were transplanted ≥ 12 months from diagnosis. The patients had received a median of 2 prior therapies (range 1–4). The majority (81%) were chemotherapy sensitive at the time of transplantation. The median follow-up of surviving patients is 27 months ( range 3–74). All patients received a BEAM (C) - based regimen [carmustine, etoposide, cytarabine, melphalan or cycylophosphamide] +/− anti-CD20 monoclonal antibodies. There was no difference in the 2-year EFS for patients failing CHOP vs. CHOP-R (60% vs. 68%, p=0.49). In addition, there was no difference in the 2-year overall survival (OS) of patients failing CHOP vs. CHOP-R (72% vs. 68%, p=0.63). In a multivariate analysis, the only factor predicting for an event (relapse or death) post-transplant was having received ≥ 2 prior chemotherapies (Relative Risk (RR) 7.5, p=0.048) and predicting for death from any cause was chemotherapy resistance (RR 2.5, p=0.037) and an increased lactic dehydrogenase at transplant (RR 4.1, p=0.002). The additional use of a monoclonal antibody with the transplant regimen did not significantly impact outcome in this analysis. This study demonstrates that patients with DLBCL failing CHOP-R are able to be salvaged with high-dose chemotherapy and autologous stem cell transplantation and have a similar 2-year EFS and OS as patients being transplanted following CHOP failure.

Radiotherapy Post Autologous Stem Cell Transplantation in Patients with Lymphoma Not Reached Complete Response.

Blood ◽  
2005 ◽  
Vol 106 (11) ◽  
pp. 5473-5473
Author(s):  
Naibai Chang ◽  
Xichun Gu ◽  
Ling Zhu ◽  
Jianping Wei ◽  
Shengming Zhao ◽  
...  
Keyword(s):  
Overall Survival ◽  
Stem Cell ◽  
Stem Cell Transplantation ◽  
Cell Transplantation ◽  
Autologous Stem Cell Transplantation ◽  
Disease Free Survival ◽  
Complete Response ◽  
Hematologic Toxicity ◽  
Free Survival ◽  
Disease Free

Abstract Objective: Anthracycline-based chemotherapy induces 50%–70% of CR in patients with lymphoma, but only 30%–40% of long-term disease-free survival. Salvage chemotherapy with autologous stem cell rescue is required in patients with aggressive disease or never achieve CR with conventional chemotherapy,but the relapsed rate is still high. The purpose of this study was to evaluate radiotherapy post autologous stem cell transplantation in such group of patients. Methods: 15 patients who underwent autologous stem cell transplantation during 1992–1998 were enrolled in this study. Conditioning regimen was CBV (cyclophosphomide + carmustine + etoposide). Radiotherapy was started on day +50(31–90). All patients were followed up until January 2005. Kaplan-Mier survival analysis was made by using SPSS10.0 software. Results: There were 14 patients with non-Hodgkin lymphoma and 1 with Hodgkin disease enrolled. Male:female=11:4. Median age was 40 (30–64). At least 6 cycles of induction chemotherapy were given before transplantation. There were 3 patients in progression disease, 1 in stable disease, and 11 in partial remission before transplantation. Three patients received total lymph node irradiation (TLI). Seven patients received TBI(200cGY)+involved field irradiation therapy(IFIT). Five were treated with IFIT. All patients acheaved complete response(including 1 CRu) after radiotherapy. Three patients relapsed. One patient treated with TBI+IFIT relapsed at 6 months later. Two patients treated with IFIT relapsed at 8 and 36 months later respectively. The mean disease-free survival and overall survival were 10.84(SD1.37,95%CI) years and 11.89(SD1.35,95%CI) years respectively. The estimatrd 10-year disease-free survival and Overall survival were both 73%. One patient developed AML at 86 month. Grade III–IV hematologic toxicity was seen in 2 patients. Conclusions: Post ASCT radiotherapy is safe and tolerated. Relaps rate is low. Patients who received TLI or TBI+IFIT seem to have better outcome than that received IFIT only.

Stem Cell Transplantation (SCT) Improves Survival in Acute Biphenotypic (ABL) and Acute Undifferentiated Leukemia (AUL): A Single Centre Experience.

Blood ◽  
2007 ◽  
Vol 110 (11) ◽  
pp. 1093-1093
Author(s):  
Sujaatha Narayanan ◽  
Michael J. Barnett ◽  
Yasser R. Abou Mourad ◽  
Donna L. Forrest ◽  
Donna E. Hogge ◽  
...  
Keyword(s):  
Overall Survival ◽  
Multivariate Analysis ◽  
Stem Cell ◽  
Complete Remission ◽  
Stem Cell Transplantation ◽  
Cell Transplantation ◽  
Standard Dose ◽  
High Dose ◽  
High Dose Therapy ◽  
Dose Therapy

Background: ABL and AUL are associated with an unfavourable outcome for patients (pts) treated with standard-dose therapy alone. Although high-dose therapy has been used successfully in this population, the optimal management of pts with ABL/AUL remains unclear. Methods: A retrospective review was performed involving 24 adult pts with ABL or AUL who were treated in Vancouver between 1984 and 2006. Kaplan-Meier estimates were utilized for event-free survival (EFS) and overall survival (OAS) and a multivariate analysis was performed to determine factors predictive of outcome. Characteristics: Utilizing the WHO criteria, 18 pts had ABL and 6 pts had AUL. There were 17 males and 7 females with a median age of 37 (range 22–75) years. Median white cell count (WCC) at presentation was 10.1 × 109(range: 0.9–196 × 109)/L. Seven pts had poor-risk karyotypes (3 pts complex, 3 pts with t(9,22), 2 pts with11q23 rearrangement, and 1 pt with monosomy 7),12 pts had standard-risk karyotypes, and 5 pts had an unknown karyotype. Induction chemotherapy consisted of Cytosine arabinoside (3–6/m2/day), Daunorubicin, Vincristine and Prednisone with one pt with t(9,22) also having received Imatinib Mesylate. Thirteen pts went on to receive high-dose therapy and SCT. Stem cell source was autologous in 3 pts (all with AUL) or a related (6 pts) or an unrelated donor (4 pts). Eight of 10 pts were in complete remission at the time of SCT, one was in relapse and one had primary refractory ABL. Conditioning was TBI-based in 10 pts and Busulfan-based in 3 pts. Results: EFS and OAS estimates for all 24 patients at 3 years were 25% (95% CI 13%–50%) and 32% (95% CI 17%–58%), respectively. The non-relapse mortality (NRM) for the whole group at 3 years was 43% (95%CI 15%–61%). On multivariate analysis, when compared to pts receiving only standard-dose chemotherapy, pts who underwent high-dose therapy had significantly improved EFS [39% (95% CI 19%–77%) vs. 9% (95% CI 1%–59%), p=.03] and OAS [46% (95% CI 26%–83%) vs.14% (95% CI 3–74%), p=0.01], respectively. Age, WCC at presentation and cytogenetic risk group were not found to significantly influence outcome. Conclusion: Although patient numbers are limited, this experience would suggest that patients with ABL/AUL who achieve complete remission with standard chemotherapy should be considered for high-dose therapy and stem cell transplantation. This approach provides them with the greatest probability of long-term event- free and overall survival.

High-Dose Therapy in AL Amyloidosis: A Prospective Phase II Study by the Dutch-Belgian Cooperative Group (HOVON)

Blood ◽  
2008 ◽  
Vol 112 (11) ◽  
pp. 163-163 ◽  
Author(s):  
Bouke P.C. Hazenberg ◽  
Sandra Croockewit ◽  
Ron van der Holt ◽  
Sonja Zweegman ◽  
Gerard Bos ◽  
...  
Keyword(s):  
Clinical Response ◽  
Phase Ii Study ◽  
Cell Clone ◽  
Performance Status ◽  
Complete Response ◽  
High Dose ◽  
Al Amyloidosis ◽  
Newly Diagnosed ◽  
High Dose Therapy ◽  
Cardiac Ejection Fraction

Abstract Background: AL amyloidosis is generally caused by a kappa or lambda light-chain producing plasma cell clone in the bone marrow. High-dose melphalan (HDM) followed by autologous stem cell transplantation (ASCT) is effective in AL amyloidosis. Pretreatment of these patients with vincristine, doxorubicin and dexamethasone (VAD) may have a rapid and additive effect on the underlying plasma cell clone. Objective: To study the feasibility and efficacy of VAD followed by HDM and ASCT in AL amyloidosis. Patients and Methods: In a prospective multicenter phase II study, the Dutch-Belgian Hemato-Oncology Cooperative Group (HOVON) studied the effect of three courses of VAD followed by HDM with ASCT on hematological and clinical response rates and overall survival in AL amyloidosis. Untreated patients aged ≤ 65 years with proven AL amyloidosis and monoclonal gammopathy or multiple myeloma stage I were included. Patients with recent prior malignancy, other types of amyloidosis, and severe other diseases not related to AL amyloidosis were excluded. High risk was defined as cardiac septum ≥ 15 mm, cardiac ejection fraction ≤ 55%, creatinine &gt; 177 μmol/L, or bilirubin &gt; 34 μmol/L (Dispenzieri et al, J Clin Oncol2001; 19:3350–6). All patients were treated with VAD or dose-modified VAD and after the third course re-evaluated. Patients were judged eligible for stem cell collection and ASCT if WHO performance status 0–2, NYHA class 1–3, cardiac ejection fraction &gt;45%, and no severe other disease. Hematological response was defined as complete response (disappearance of monoclonal protein in blood and urine, and no clonal excess of plasma cells in bone marrow), partial response (greater than 50% reduction in serum and urine monoclonal proteins), persistence, and progression (doubling of monoclonal protein in serum or urine). Clinical response was defined as organ response, stabilization, or progression (Gertz et al, Am J Hematol2005; 79:319–28). Results: Sixty-nine newly diagnosed patients with AL amyloidosis were included between September 2000 and January 2006: 37 men and 32 women with a median age of 55 years and WHO performance status 0–2. Organ involvement was renal in 58 (84%), cardiac in 32 (46%), hepatic in 12 (17%), and neuropathic in 18 (26%); 15 patients (22%) had involvement of 3 or 4 organs. Thirty-seven (54%) could be classified as high-risk patients. Forty-six patients (67%) could proceed to HDM (140–200 mg/m2) after VAD induction. The transplants were performed in tertiary referral centres. Median haematological recovery time of ANC &gt; 1.0 × 109/L and platelets &gt; 50 × 109/L was 17 and 21 days, respectively. End of survey was November 2007. Overall hematological response was 39% including 16% with a complete response. Overall clinical response was 26% and stabilization in 35%. In 43% of patients only the clinical response could be assessed. Overall survival of all patients was median 60 months and had not been reached for the transplanted patients (Figure). Nine patients died from TRM (11%), 7 during VAD and 2 following HDM. Side effects CTC grade ≥ 2 were recorded in 46% of patients during VAD induction and in 87% of patients after HDM; infections CTC grade ≥ 2 were recorded in 13% and 65%, respectively. Conclusions: VAD induction followed by HDM and ASCT for AL amyloidosis is feasible, has acceptable TRM, and results in a remarkable prolonged survival. This two-step approach of induction with non-intensive chemotherapy in all patients followed by HDM with ASCT in eligible patients is now recommended as standard treatment by HOVON for newly diagnosed patients with AL amyloidosis who are eligible for high-dose therapy. Figure Figure

Randomized study of docetaxel (D) and dexamethasone (DX) with low or high dose estramustine (E) for patients with advanced hormone-refractory prostate cancer (HRPC)

2006 ◽  
Vol 24 (18_suppl) ◽  
pp. 4653-4653
Author(s):  
T. Nelius ◽  
T. Klatte ◽  
F. Reiher ◽  
S. Filleur ◽  
R. Yap ◽  
...  
Keyword(s):  
Overall Survival ◽  
Side Effects ◽  
Bone Pain ◽  
Performance Status ◽  
Univariate Analysis ◽  
Total Daily Dose ◽  
High Dose ◽  
Ecog Performance Status ◽  
Significant Difference ◽  
Psa Response

4653 Background: D-based chemotherapy is a burgeoning option for men with advanced HRPC. Alone or in combination with E, D has been shown to improve median survival. In this study we tested the combination of D with two different doses of E in patients (pts) with HRPC to improve response rates and to lower side effects. Methods: 72 metastatic HRPC pts were randomly assigned to receive D (70 mg/m2 IV, d2, q3w) and E (3 × 280 mg/d PO starting 1 day prior to D, for 5 consecutive days) for arm A or E (3 x 140 mg/d PO starting 1 day prior to D, for 3 consecutive days) for arm B. Premedication with oral DX at a total daily dose of 16 mg, in divided doses two times a day was administered in arm A on day 1 to 5 and in arm B on day 1 to 3. Initially, 6 cycles were administered and repeated after significant PSA rise. Pts were monitored for PSA response, time to progression (TTP), survival and toxicity. Results: PSA declines of ≥75%, ≥50% and ≤50% were 36.8%, 55.3% and 44.7% in arm A and 38.2%, 67.6% and 32.4% in arm B, respectively (P = .442). TTP in Arm A and Arm B were 11 months (95% CI, 7–14) versus 14 months (95% CI, 8–19), P = .6911) and overall survival 21 months (95% CI, 6–35) versus 22 months (95% CI, 18–27), respectively, (P = .4149). The primary treatment-related side effects observed in arm A and arm B were granulocytopenia (34% and 29%, P = .663) and thrombotic complications caused by E (four pts (11%) and one pt (3%), respectively, P = .206). Associated baseline factors with overall survival in univariate analysis were ECOG performance status (P < .001), hemoglobin level (P < .001), bone pain (P < .001), and PSA (P < .097) and in multivariate analysis ECOG performance status (95% CI, 2.9–13.9) and bone pain (95% CI, 3.2–20.1), (P < .001). Conclusions: In this randomized phase II study the combination of D and E had substantial activity in HRPC. We did not find a statistically significant difference of higher dose of E in combination with D compared to a lower dose of E and D regarding PSA response, TTP and survival. However, there was a tendency of higher toxicity in the high dose E group. These treatment-related toxicities were mainly hematologic and manageable. The results of this study support the assertion that estramustine is not necessary in docetaxel-based treatment regimens. No significant financial relationships to disclose.

Feasibility of risk stratified allocation to single versus tandem autologous SCT in multiple myeloma.

2012 ◽  
Vol 30 (15_suppl) ◽  
pp. e18550-e18550
Author(s):  
Matthew Risendal ◽  
Allison Hazlett ◽  
Roy T. Sabo ◽  
Priscilla Mpasi ◽  
Joan Bolling ◽  
...  
Keyword(s):  
Multiple Myeloma ◽  
Overall Survival ◽  
Relapse Rate ◽  
Survival Rates ◽  
Complete Response ◽  
High Dose ◽  
High Dose Therapy ◽  
Current Standard ◽  
Prognostic Features ◽  
Dose Therapy

e18550 Background: Multiple myeloma (MM) is a plasma cell malignancy with variable prognosis depending on disease features such as β2m and cytogenetics. High dose therapy and stem cell transplantation (SCT) remains the current standard of care for MM, however the role of tandem SCT is controversial, particularly in the era of novel induction therapy. Methods: Our program has a practice of risk-stratified transplant allocation in MM patients referred for SCT, those with high-risk (HR) disease (β2m >5.5, adverse cytogenetics, >1st remission) are preferentially assigned tandem SCT, and those with standard risk (SR), a single SCT. Between 2008 and 2011, 129 MM patients underwent SCT, 43% SR patients received a single SCT (SRS), 22% HR received tandem SCT (HRT) & 36% HR a single SCT (HRS). Median age at SCT was 57 years. Maintenance therapy was administered in 51% SRS, 57% HRT & 67% HRS patients. Results: Complete response (CR) or very good partial response was achieved in 0.68, 0.72 and 0.80 for the HRT, HRS, and SRS groups. The HRT group (0.39) was more likely to achieve CR than HRS (0.20) (P=0.02). At a median follow up of 23.4 months, the overall survival for HRS was inferior to SRS (P=0.01) but there was no difference in the overall survival between HRT and SRS cohorts. Two-year survival rates were 0.81, 0.91 and 0.97 in the HRS, HRT and SRS cohorts (HRS vs. SRS P=0.02). This was attributable to a higher 1-year relapse rate in HRS (0.29) compared to HRT (0.07) and SRS (0.07) (P<0.01). Conclusions: Using a risk-stratified allocation system, we report that HR MM patients undergoing tandem SCT have outcomes comparable to SR patients. However, HR MM patients receiving a single SCT have inferior outcomes compared to those with SR. Notably, higher rate of CR and a lower relapse rate were observed in the HRT cohort when compared to HRS. This suggests that greater depth of remission achieved in HR patients undergoing tandem SCT may result in longer time to relapse and survival advantage compared to HR patients receiving a single SCT. In contrast, a single SCT may suffice for SR MM patients. These results demonstrate that risk-stratification based on disease prognostic features is an important treatment consideration when planning high dose therapy in MM patients.

Successful Treatment of AL Amyloidosis Patients over Age 65 with High-Dose Melphalan and Autologous Stem Cell Transplantation (HDM/SCT).

Blood ◽  
2004 ◽  
Vol 104 (11) ◽  
pp. 923-923
Author(s):  
David Cary Seldin ◽  
Jennifer J. Anderson ◽  
Martha Skinner ◽  
Karim Malek ◽  
Daniel G. Wright ◽  
...  
Keyword(s):  
Stem Cell ◽  
Performance Status ◽  
Treatment Protocol ◽  
Complete Response ◽  
Median Number ◽  
Rank Test ◽  
High Dose ◽  
Al Amyloidosis ◽  
Younger Patients ◽  
Related Mortality

Abstract Over the past 10 years, HDM/SCT has been employed for treatment of patients with AL amyloidosis. Although peri-transplant mortality is greater than for other hematologic diseases, HDM/SCT leads to durable hematologic complete responses (CR), improvements in organ function, and extended survival in a substantial proportion of patients (Skinner et al., Ann. Int. Med. 2004). In that study, the proportion of patients eligible for HDM/SCT was lower for patients >65 years of age than for younger patients (34.3% vs. 68.4%), but the hematologic complete response (CR) rate and survival appeared to be no different. Here, we update these results and present a detailed analysis of outcomes in patients >65 vs. those <65. Data were collected with IRB approval. Through 07/01/04, 349 patients began G-CSF mobilization, of which 66 (19%) were >65. The median age of the 66 patients was 68, range 65–80; 73% male; 18% ? and 82% ?, while for the 283 patients <65, the median age was 55, range 29–64; 57% male; 16% ? and 84% ?. The median number of involved organs was no different in the two groups, nor was the type of organ involvement or performance status. There was also no difference in the rate of serious complications during stem cell collection, as a similar fraction of patients in both groups did not proceed to transplant, 12.1% of patients >65 versus 10.3% of patients <65 (p=.659). Based on treatment protocol, only 19% of patients >65 received an IV dose of melphalan of 200 mg/m2 (the remainder being treated with 140 mg/m2 or less), vs. 64% of those <65 (p <.001). There was no difference in early transplant-related mortality (10.3% in patients >65 vs. 13.4% in patients <65, p=.665). There was also no difference in one year mortality (22.4% for those >65 vs. 20.9% for those <65, p=.859). There was a non-significant trend towards a lower rate of hematologic CR in the older patients (32% vs. 44%, p=0.155). However, the median survival after HDM/SCT was no different (see fig; 4.9 years for patients >65 vs. 4.6 years for those <65, p=0.42 by log-rank test). Thus, while fewer patients >65 meet eligibility requirements for HDM/SCT, for those who do, treatment-related mortality, hematologic CR rate, and survival are no different than for younger patients. These data strongly support the use of HDM/SCT for suitable patients with AL amyloidosis who are >65 years old. Figure. Figure.

Role of Second Stem Cell Transplant in Patients with Amyloidosis Who Are Refractory or Relapsing.

Blood ◽  
2005 ◽  
Vol 106 (11) ◽  
pp. 5469-5469
Author(s):  
Morie Abraham Gertz ◽  
Martha Q. Lacy ◽  
Angela Dispenzieri ◽  
Suzanne R. Hayman ◽  
Shaji K. Kumar ◽  
...  
Keyword(s):  
Stem Cell ◽  
Light Chain ◽  
Stem Cell Transplant ◽  
Complete Response ◽  
Free Light Chain ◽  
High Dose ◽  
Cell Transplant ◽  
High Dose Therapy ◽  
Single Organ

Abstract Introduction: Stem cell transplant is an increasingly widely applied technique for managing amyloidosis. As in multiple myeloma, the treatment would not be expected to be curative and patients would be expected to relapse in most instances. In addition, approximately one-third of patients fail to respond to initial therapy. The role of second transplantation in treatment failures or patients who relapse is reviewed. Patients: Of 242 patients undergoing high dose conditioning and stem cell transplantation for amyloidosis (AL) at the Mayo Clinic, 6 subsequently underwent a second transplant. Results: Patient 1, who had single organ renal amyloid nephrotic syndrome responded and relapsed at 73 months, received a second stem cell transplant achieving a hematologic complete response with normalization of a markedly elevated pre transplant free light chain (59 to 1.9 mg/dL) and is alive at 12 months. Patient 2 relapsed 42 months after transplant for single organ renal amyloidosis; the second stem cell transplant, has normalized his free light chain ratio reduced his urinary protein loss from 5450 to 1482 mg/day and he is alive 21 months following his second transplant (63 months overall). Patient 3 relapsed 34 months after a response of renal and cardiac amyloidosis. After transplant two, he failed to achieve a 50% reduction in his free light chain, began hemodialysis 7 months post transplant and died one year post transplant. Patient 4 with single organ cardiac involvement relapsed 30 months following his first transplant and died on day +5 of his second transplant of an acute pulmonary embolus. Patient 5 was a response failure after his first transplant, had a second transplant 35 months later, having failed Dexamethasone followed by Melphalan/Dexamethasone therapy, and died 3 months later of progressive disease. Patient 6 had single organ vascular involvement manifest by calf and thigh claudication and failed to respond with his first transplant with a persistently elevated free light chain. The second transplant was performed six months after the first without further free light chain reduction and persistent claudication at 11 months. Conclusion: Patients who failed to achieve a hematologic response after a first transplant appear not to benefit from a second course of high dose therapy. Among 4 patients who were previously responsive and relapsed, one achieved a hematologic complete response, one achieved a hematologic partial response, and two died. The two patients achieving a second hematologic response had the longest response duration (73 and 42 months) following their first transplant, and the second response presumably reflects favorable (indolent; non proliferative) biology of the underlying plasma cell dyscrasia. High dose therapy and stem cell transplant may be an effective salvage regimen for patients who responded to a first transplant and whose response lasted greater than 36 months.

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