Peripheral T-Cell Lymphomas (PTCL) Treated With Or Without Upfront Autologous Stem Cell Transplantation: Results Of a Retrospective Single Center Analysis

Blood ◽  
2013 ◽  
Vol 122 (21) ◽  
pp. 5548-5548
Author(s):  
Alice Di Rocco ◽  
Angelo Fama ◽  
Eleonora Russo ◽  
Giovanna Meloni ◽  
Paolo Paesano ◽  
...  
Keyword(s):  
Bone Marrow ◽  
Stem Cell ◽  
T Cell ◽  
High Risk ◽  
Bone Marrow Involvement ◽  
Prognostic Index ◽  
Intermediate Risk ◽  
Consolidation Therapy ◽  
T Cell Lymphomas ◽  
Peripheral T Cell Lymphomas

Abstract Peripheral T-cell lymphomas (PTCLs) are a heterogeneous group of rare diseases, characterized by an aggressive behavior and a poor clinical outcome. High-dose therapy followed by autologous stem cell transplantation (ASCT) has been used as salvage and upfront treatment with conflicting results. However, no standard therapy has so far been established due to the lack of randomized studies. The records of 54 untreated patients with a confirmed diagnosis of PTCL managed at our Institute between 2001 and 2011 were reviewed. The histologic subtypes were: 37 (68%) peripheral T-cell lymphomas unspecified (PTCL-U), 13 (24%) anaplastic large cell lymphomas (ALCL), of which 4 (30%) ALK-positive, 2 (4%) angio-immunoblastic lymphomas (AITL) and 2 (4%) enteropathy-associated T-cell lymphomas (EATL). The clinical characteristics were: median age 56 years (range 18-79); 40 men and 14 women; 13 (24%) and 41 (76%) patients were, respectively, in Ann Arbor stages I-II and III-IV. An elevated serum LDH was present in 33% of patients, 48% had B symptoms and 24% had a bone marrow involvement. The ECOG performance status was 2-3 in 28% of patients. According to the International Prognostic Index (IPI) and the prognostic index for T-cell lymphomas (PIT), 11% and 22% were classified as low risk, 30% and 33% as low-intermediate risk, 12% and 33% as high-intermediate risk and 29% and 12% as high risk, respectively. CHOP-like regimens were given to 32 (59%) patients, 14 of whom received the CHOEP regimen. The remaining 22 (41%) patients were treated with more intensive third generation regimens (MACOP-B like). ASCT was planned as upfront consolidation therapy for 16/54 (30%) patients. A complete response (CR) was obtained in 30/54 (55.5%) patients, a partial response in 7 (13%), while 17 (31.5%) patients showed a lymphoma progression during induction therapy. No difference in terms of CR rate was observed between the CHOP-like and MACOP-B-like regimens. At a median follow-up of 19 months (range 3-138), the 5-years OS and 5-years PFS were 32% (95% CI 25.3-38.5) and 27% (95% CI 20.2-34.5), respectively. At univariate analysis, bone marrow involvement (p=0.003), PIT high risk group (p<0.001) and lymphocytopenia (p=0.06) predicted a shorter PFS. Five of 16 (31%) patients did not receive the planned ASCT consolidation due to early progression. Patients who received an ASCT as consolidation therapy presented a slightly better 5-year PFS than patients treated with chemotherapy alone (95% CI 37.7% vs 25%; p=0.08). The prognosis of PTCLs remains poor despite the use of intensive chemotherapy regimen including upfront ASCT. More active induction chemotherapy regimens, including novel agents, should be designed in an attempt to increase the quality of response before ASCT consolidation therapy. Disclosures: No relevant conflicts of interest to declare.

Improved Outcome After Allogeneic Stem-Cell Transplantation (SCT) As Compared to Non-Allogeneic SCT Therapies in Patients with High-Risk Peripheral T-Cell Lymphomas in First Response.

Blood ◽  
2012 ◽  
Vol 120 (21) ◽  
pp. 3111-3111
Author(s):  
Margot Robles ◽  
Loic Ysebaert ◽  
Stephane Vigouroux ◽  
Anne Huynh ◽  
Marie Parrens ◽  
...  
Keyword(s):  
Stem Cell ◽  
T Cell ◽  
High Risk ◽  
Stem Cell Transplantation ◽  
First Line ◽  
First Line Therapy ◽  
Line Therapy ◽  
T Cell Lymphomas ◽  
Alk Positive ◽  
Peripheral T Cell Lymphomas

Abstract Abstract 3111 Peripheral T-cell lymphomas (PTCL) are a heterogeneous group of rare malignancies usually occurring in middle-aged to elderly patients (pts), with an advanced disease and unfavorable international prognostic index (IPI) scores. Excluding ALK-positive anaplastic large cell lymphomas (ALCL) and indolent mycosis fungoides, they are often characterized by a poor prognosis. There is no consensus about optimal therapy and the role of allogeneic stem-cell transplantation (allo-SCT) as first line therapy remains to be investigated. In an effort to explore this therapeutic option in younger pts, we undertook a retrospective analysis in 2 french centers. The records of all pts aged between 18 and 65 years diagnosed with PTCL in Bordeaux and Toulouse between January 2005 and April 2012 were reviewed. Cutaneous T-cell lymphomas and ALK-positive ALCL were excluded. Patients with an IPI score at diagnosis of 0/1 were excluded as well as those who never reached at least a 1st partial response according to the criteria reported by Cheson. Patients relapsing within 3 months after the 1st response and thus ineligible for allo-SCT were also excluded. The primary objective was to compare the outcome of allo-SCT (allo group) as compared to non-allogeneic SCT therapies (no-allo group) in these pts with high-risk PTCL in 1st response. Thirty-three patients were included (16 in the allo group, 17 in the no-allo group). Fifteen pts in the allo group were treated in Bordeaux where allo-SCT was always pursued during the study period in responding pts with an IPI score ≥ 2 at diagnosis. In Bordeaux, the absence of allo-SCT in 1st response was explained by the absence of a suitable donor or the refusal of the patient. The therapeutic strategy in Toulouse was different with 11 pts in the no-allo group, allowing us to undertake this retrospective comparison. In the allo group, conditioning regimes were of reduced intensity (n=12) or myeloablative (n=4). The sources of stem cells were PB (n=13), BM (n=2) or cord blood (n=1). Donors were matched related (n=7), matched unrelated (n=6), mismatched unrelated (n=2). In the whole cohort, the first chemotherapy regimes were CHOP or CHOP-like (n=31), DHAP (n=1), ICE (n=1). In the allo vs no-allo groups, the median ages at diagnosis were 54 years (20–65) vs 59 years (29–64), p = 0.5; the number of pts diagnosed before 2009 were 7 vs 9, p=0.6; the lymphoma subtypes were PTCL-NOS (4 vs 9, p=0.1), angioimmunoblastic (8 vs 6, p=0.4), others (4 vs 2, p=0.3); the IPI scores at diagnosis were 2 (5 vs 5, p=0.9), 3 (6 vs 3, p=0.2), 4/5 (5 vs 9, p=0.2); the number of pts in CR1 and PR1 were 13 vs 13, p = 0,7 and 3 vs 4, p=0.7; the number of chemotherapy lines to reach the 1st response were 1 (8 vs 15, p=0.02), 2 (4 vs 2, p=0.3) or 3 (4 vs 0, p=0.03). Five patients in the no-allo group were treated with an autologous SCT in 1st response. Three patients in the allo group were treated with autologous SCT to reach the 1st response. With a median follow-up of 34 months (8–74) after the 1st response, in the allo vs no-allo groups, the 2-year OS (figure 1) were 87% ± 8% vs 49% ± 13%, respectively (p= 0.06); the 2-year EFS (figure 2) were 81% ± 10% vs 33% ± 12%, respectively (p = 0.007). In the allo and no-allo groups, 3 and 12 pts respectively, have relapsed. In the allo and no-allo groups, 2 and 8 pts respectively, have died, all from disease progression. The modest size of our study and the potential biases inherent to such a restrospective design preclude the declaration of any firm conclusion. However, these preliminary data suggest that patients under 65 years of age with high-risk PTCL (IPI ≥2) might benefit from allo-SCT in 1st response, in comparison with non-allogeneic SCT therapies. Randomized studies are warranted to further delineate the optimal first line therapy in these patients. Our center is currently participating to such an ongoing european study comparing allo-SCT vs auto-SCT. Figure 1 Figure 1. Figure 2 Figure 2. Disclosures: No relevant conflicts of interest to declare.

Efficacy of a Dose-Intensified CHOP (Double-CHOP) Regimen for Peripheral T-Cell Lymphomas

Blood ◽  
2012 ◽  
Vol 120 (21) ◽  
pp. 4855-4855
Author(s):  
Hiromichi Takahashi ◽  
Noriyoshi Iriyama ◽  
Yoshihiro Hatta ◽  
Katsuhiro Miura ◽  
Yujin Kobayashi ◽  
...  
Keyword(s):  
Stem Cell ◽  
T Cell ◽  
Conflicts Of Interest ◽  
International Prognostic Index ◽  
Prognostic Index ◽  
High Dose ◽  
Chop Regimen ◽  
Anaplastic Lymphoma ◽  
T Cell Lymphomas ◽  
Peripheral T Cell Lymphomas

Abstract Abstract 4855 Background: Peripheral T-cell lymphomas (PTCLs) are a rare and heterogeneous group of non-Hodgkin lymphomas, often resulting in poor prognoses. The CHOP chemotherapy regimen, which includes cyclophosphamide, doxorubicin, vincristine, and prednisone, had been used previously to treat other types of lymphomas. Here, we examined the efficacy and safety of a dose-intensified CHOP regimen (Double-CHOP), which was followed by autologous stem-cell transplantation (ASCT) or high-dose methotrexate (HDMTX), in PTCL patients. Patients and Methods: Twenty-eight PTCL patients, who received 3 courses of Double-CHOP at our institution, were retrospectively studied from 1996 to 2012. Patients with anaplastic lymphoma-kinase-positive anaplastic large-cell lymphoma (ALK+–ALCL) were excluded from this study. The Double-CHOP regimen consisted of 3 courses of intravenous (iv) administration of cyclophosphamide (750 mg/m2, days 1–2, over 2 h), doxorubicin (50 mg/m2, days 1–2, over 30 min), vincristine (1.4 mg/m2, day 1, max 2 mg/Kg body weight), and per os (p.o.) prednisone (50 mg/m2, days 1–5). For patients aged >60, cyclophosphamide and doxorubicin doses were modified. The third cycle of Double-CHOP regimen was used for stem cell mobilization. Consolidating high-dose therapy (HDT) regimen consisted of cyclophosphamide (60 mg/kg, day 6 and 7, iv, over 3 h), etoposide (500 mg/m2; day 4, 5, and 6; iv; over 6–8 h), and ranimustine (250 mg/m2, day 2 and 3, iv, over 1 h). ASCT was performed on day 0 and G-CSF administered from day 1 until neutrophil engraftment. As an alternative to HDT/ASCT, HDMTX (8 g/m2, day 1, iv, over 4 h) was indicated for patients who could not yield a sufficient number of stem cells or were ineligible for HDT/ASCT. Results: Patients' median age was 58 years (range: 17–69). They had low-intermediate (n = 11), high-intermediate (n = 10), or high (n = 7) risk according to the International Prognostic Index (IPI). The overall complete remission (CR) rate following Double-CHOP treatment was 68%. Of all the CR patients, 10 could successfully tolerate a consolidated HDT followed by ASCT, and 7 received HDMTX. Only a single case of treatment-related mortality was recorded during the study. On a median 31-month follow-up, the estimated 3-year overall survival (OS) rate and 3-year relapse-free survival (RFS) rate after CR were 68% and 60%, respectively. Conclusion: Although this study included elderly and excluded low-risk IPI and ALK+–ALCL patients, both RFS and OS results were superiorly favorable, indicating the efficacy of this Double-CHOP regimen and Double-CHOP followed by ASCT/HDMTX consolidations is safe and may achieve prolonged EFS, especially in patients with poor prognostic factors. However, an effective treatment strategy for refractory or relapsing patients needs to be validated and established. Disclosures: No relevant conflicts of interest to declare.

Frontline Autologous Stem Cell Transplantation As Intensive Consolidation in Patients with Peripheral T Cell Lymphomas: Multicenter Phase II Trial in Korea

Blood ◽  
2011 ◽  
Vol 118 (21) ◽  
pp. 4477-4477 ◽  
Author(s):  
Jae-Sook Ahn ◽  
Deok-Hwan Yang ◽  
Yee Soo Chae ◽  
Sang Kyun Sohn ◽  
Jae-Yong Kwak ◽  
...  
Keyword(s):  
Stem Cell ◽  
T Cell ◽  
High Risk ◽  
Cell Lymphoma ◽  
Conditioning Regimen ◽  
Large Cell ◽  
T Cell Lymphoma ◽  
T Cell Lymphomas ◽  
Large Cell Lymphoma ◽  
Peripheral T Cell Lymphomas

Abstract Abstract 4477 Peripheral T cell lymphomas (PTCLs) are an aggressive subtype of non-Hodgkins lymphoma and they have shown the shorter survival compared with B cell lymphoma. High-dose chemotherapy (HDT) followed by autologous stem cell transplantation (HDT/ASCT) for PTCLs has a potential meaning of consolidating remission for PTCLs. However, the effectiveness of ASCT on distinct conditioning regimens, the optimal transplant timing in the frontline or relapsed are still unclear. We investigated the clinical outcomes of HDT/ASCT as frontline intensification in 46 patients with newly diagnosed PTCLs except ALK(+) anaplastic large cell lymphoma. Patients underwent ASCT with a uniform conditioning regimen (busulfex, cyclophosphamide and etoposide). The median age was 47 years (17–65). The histological subtypes were 47.9% PTCL-NOS (n=23), 18.8% anaplastic large cell lymphoma (n=9), 4.2% angioimmunoblastic T cell lymphoma (n=2), 25% extranodal NK/T cell, nasal type (n=12), 2.1% hepatosplenic T cell lymphoma (n=1) and 2.1% enteropathy-associated T cell lymphoma. Thirty patients (62.6%) presented with advanced stage disease (III/IV) and 16 (33.3%) had B symptoms. At diagnosis, 21 patients (43.8%) were classified as high-intermediate/high risk by the age-adjusted IPI (aaIPI) and 10 (20.9%) were classified as high-risk (more than 2 factors) by the prognostic index for PTCL (PIT). Thirty-one patients (67%) could undergo HDT/HSCT and disease status at pretransplant consisted of 23 patients (50 %) with CR and 8 patients (17.4%) with PR. 6 out of 8 patients with PR at pretransplantation improved the response to CR after HDT/ASCT. There was no significant difference of the response rate between CHOP alone or CHOP-like chemotherapy and non-anthracycline-based chemotherapeutic regimen. At a median follow-up of 32.9 months, 23 patients (50%) are alive. The 5-year probability of overall and progression-free survival (PFS) was 48.2 ± 8.1 % and 47.4 ± 8.1%, respectively. However, the 5-year OS and PFS rate in transplanted patients was 57.3± 10.2 % and 55.3 ± 11.3 %, respectively. Conclusion: Frontline HDT/ASCT in patients with PTCL could be performed with a high response rates and a substantial impact on improving outcome for PFS. Our findings also indicate that busulfex, cyclophosphamide and etoposide is a feasible conditioning regimen in ASCT for PTCLs. Disclosures: No relevant conflicts of interest to declare.

Prognostic value of T-cell receptor γ rearrangement in peripheral blood or bone marrow of patients with peripheral T-cell lymphomas

2008 ◽  
Vol 49 (2) ◽  
pp. 237-246 ◽  
Author(s):  
Christian SchüTzinger ◽  
Harald Esterbauer ◽  
Gregor Hron ◽  
Cathrin Skrabs ◽  
Martin Uffmann ◽  
...  
Keyword(s):  
Bone Marrow ◽  
T Cell ◽  
T Cell Receptor ◽  
Peripheral Blood ◽  
Prognostic Value ◽  
Cell Receptor ◽  
T Cell Lymphomas ◽  
Peripheral T Cell Lymphomas

Retrospective Study on T Cell Malignent Lymphoma: Classification, Manifestation, Laboratory Finding and Survival.

Blood ◽  
2006 ◽  
Vol 108 (11) ◽  
pp. 4652-4652
Author(s):  
Hongyan Tong ◽  
Feng Xiao ◽  
Tieying Dai ◽  
Jie Jin ◽  
Haitao Meng ◽  
...  
Keyword(s):  
Bone Marrow ◽  
T Cell ◽  
Cell Lymphoma ◽  
Bone Marrow Involvement ◽  
Autologous Bone Marrow Transplantation ◽  
T Cell Lymphoma ◽  
World Health ◽  
Clinical Staging ◽  
T Cell Lymphomas

Abstract T-cell lymphoma is the special malignant type of non-Hodgkin’s lymphoma. The diagnosis and the treatment were usually troublesome for physician in clinical practice. We retrospectively reviewed 63 cases of T-cell lymphomas from 360 cases of lymphomas in our hospital during the period from January 2000 to July 2006. This study is to determine the clinicopathological characteristics of T cell lymphomas. The patients were reclassified according to the World Health Organization classification system. Clinical data, including age, gender, clinical staging, and follow-up, were scrutinized. The median follow-up duration was 5 months (range 21days to 36 months). There were slightly more males than females (36 versus 27), and the median age at the onset were 40 years (range 13 to 77 years). The major subtype was peripheral T-cell lymphoma, which accounted for 78% (49/63). Besides, there were 5 cases of anaplastic T large cell lymphoma, 3 lymphoblastic lymphoma, 2 T/NK-cell lymphoma, 2 angioimmunoblastic lymphoma, 1 mycosis fungoides and 1 pre-T cell lymphoma. The most common manifestation was fever, which accounted for 60% (38/63). 27% (17/63) patients presented with obvious enlargement of lymphonodes. Other manifestation included skin rash or phymata, pruritus, jaundice, abdominal pain, rhinorrhagia, puffiness, diarrhea, hoarseness and ulcus. Interestingly, we found that only 32% obvious enlarged lymphonodes could be confirmed by physical examination, hepatomegaly 33% and Splenomegaly 44% respectively. Besides, there were several significant laboratory findings: 40% cases had cytopenia of at least 2 cell lines, 68% had high level of LDH, 70% had elevated β2-microglobulin and 68% were detected T-cell receptor (TCR) and immunoglobulin heavy chain (IgH) gene rearrangement. Furthermore, 53% (33/63) patients had bone marrow involvement at the onset and 27% were diagnosed only by bone marrow biopsy. We also observed 20 cases of lymphoma associated hemophagocytic syndromes (LAHS). The median age for this disease was 37 year. The median life span was 39 days (range 21days to 10 months). The initial manifestations included fever (19/20), splenohepatomegaly (18/20), and cytopenias in all patients. Only 15% patients had enlargement of lymphonodes, which was suggested to be infrequent in LAHS. Immatural T-cell infiltration in bone marrow was detected in 75% (15/20) cases. Chromosome disorder of [der(21)(p11), −22] was detected in 3 cases. We also found that 2 cases which underwent plasmapheresis got much better after chemotherapy. 19 cases were under our follow-up. 17 patients could not survival longer than 6 months. The 6-month overall survival (OS) for LAHS was merely 2 of all 20. Furthermore, nobody survived more than 1 year, which indicated the poor prognosis of LAHS. There were 11 out of 63 cases had received trial chemotherapy including liposomal Doxorubicin, L-asparaginase, velcade, autologous bone marrow transplantation, or plasmapheresis before chemotherapy. The median survival time prolonged obviously from 2 months up to 8 months, which suggested the encouraging efficiency of these methods.

A Critical Analysis of Prognostic Factors in Patients with HTLV-1 Adult T-Cell Leukemia/Lymphoma: A Multicenter Clinicopathologic Experience and New Prognostic Score.

Blood ◽  
2008 ◽  
Vol 112 (11) ◽  
pp. 1784-1784
Author(s):  
Adrienne A. Phillips ◽  
Iuliana Shapira ◽  
Robert D. Willum ◽  
Jasotha Sanmugarajah ◽  
William B. Solomon ◽  
...  
Keyword(s):  
T Cell ◽  
High Risk ◽  
Median Survival ◽  
Risk Group ◽  
Performance Status ◽  
Recursive Partitioning ◽  
Prognostic Index ◽  
Low Risk ◽  
Intermediate Risk ◽  
A Performance

Abstract Purpose: Adult T-Cell Leukemia/Lymphoma (ATLL) is a rare aggressive Human T-cell Lymphotropic Virus Type-I (HTLV-I) associated peripheral T-cell neoplasm with 4 recognized clinicopathologic subtypes: acute, lymphomatous, chronic, and smoldering. Since the initial description of these variants, several studies have sought to identify additional prognostic factors. We assessed prognostic models already in use for aggressive non-Hodgkin lymphomas to develop a novel risk stratification scheme. Methods: Data regarding patients with ATLL were collected from 3 medical centers between 8/92 and 5/07. Descriptive statistics were used to assess categorical and continuous variables. Overall survival (OS) was defined as time from diagnosis to death. Survival curves for OS were estimated using the Kaplan-Meier method. Univariate associations between individual clinical factors and OS were evaluated using the log-rank test for categorical variables and the Cox model for continuous variables. Maximum logrank analysis was used to select the optimal cut-off for calcium. In order to develop a simple risk model and allow for interactions of factors independently associated with OS, we used recursive partitioning analysis. Results: 89 patients with ATLL were identified; 37 males (41.6%) and 52 females (58.4%) and median age 50 years (range 22 to 82). The acute subtype of ATLL predominated (68.5%), followed by lymphomatous (20.2%), chronic (6.8%) and smoldering (4.5%). Median OS for all sub-types was 24 weeks (range 0.9 to 315). According to the International Prognostic Index (IPI), 8 patients (9.1%) were classified as low risk, 11 patients (12.5 %) as low intermediate risk, 13 patients (14.8 %) as high intermediate risk, and 56 patients (63.6 %) as high risk, 1 patient could not be evaluated due to missing data. Median OS by IPI risk group was 271, 65, 31 and 16 weeks, respectively (p&lt;0.01). The Prognostic Index for PTCL-U (PIT) could be determined in 68 patients; 10 patients (14.7 %) had a score of 0–1 (group 1), 19 patients (27.9 %) had a score of 2 (group 2), 31 patients (45.6 %) had a score of 3 (group 3), and 8 patients (11.8 %) had a score of 4 (group 4). Median OS by PIT risk group was 61.1, 28, 24, and 11.3 weeks respectively (p&lt;0.01). A new risk model was developed using the variables of the IPI and PIT. In addition, calcium level at diagnosis was also included as it had independent prognostic value. Recursive partitioning of OS based on these variables gave a tree with 5 nodes, which fell into three risk categories: low risk patients with Stage I–II disease and a performance status &lt;2; the medium risk group composed of two sets of patients: those with Stage III–IV disease with an ECOG performance status &lt; 2 or those with an ECOG performance status ≥ 2 with calcium ≤ 11 mg/dL and age ≤ 60; and the high risk group (also comprising 2 sets of patients): those with a performance status ≥ 2 with calcium ≤ 11 mg/dL and age &gt; 60 or those with a performance status ≥ 2 and calcium &gt; 11 mg/dL. There were 10 patients (11.2%) in the low risk (median survival= 156.6 weeks), 31 (34.8%) in the intermediate risk (median survival = 45.4 weeks), and 48 (53.9%) in the high risk (median survival= 13 weeks) categories (p&lt;0.01). Conclusion: This retrospective series confirms a poor outcome for North American patients with HTLV-1 related ATLL. Although the IPI and PIT identified subsets of patients, these models had liabilities. We propose a new prognostic model based on recursive partitioning analysis that successfully identifies three prognostic categories based on performance status, stage, age and calcium level at diagnosis in a more robust and distinct fashion. Table 1. Comparison of Prognostic Scores and Kaplan Meier Survival Estimates (%) of patients with ATLL International Prognostic Index (IPI) (n = 88) Prognostic Index for PTCL-U (PIT) (n = 68) ATLL Prognostic Score (APS) (n= 89) Time (wks) Low n= 8 Low-Intermed n= 11 High-Intermed n= 13 High n= 56 Group 1 n= 10 Group 2 n= 19 Group 3 N= 31 Group 4 n= 8 Low n= 10 Intermed n= 31 High n= 48 13 8 (100%) 10 (100%) 9 (75.5%) 31 (53.1%) 10 (100%) 13 (68.4%) 19 (66.3%) 3 (25.0%) 9 (100%) 27 (87.1%) 23 (46.4%) 26 8 (100%) 9 (90.0%) 6 (56.6%) 17 (31.1%) 10 (100%) 9 (51.3%) 13 (45.4%) 0 (0%) 9 (100%) 23 (77.0%) 9 (19.9%) 52 6 (75.0%) 6 (60.0%) 3 (28.3%) 9 (17.6%) 5 (50%) 5 (28.5%) 8 (30.7%) 0 (0%) 8 (88.9%) 13 (46.0%) 4 (8.8%) 78 5 (75.0%) 4 (40.0%) 2 (18.9%) 2 (4.0%) 4 (40%) 3 (17.1%) 2 (7.7%) 0 (0%) 7 (88.9%) 7 (24.8%) 0 (0%) 104 3 (56.2%) 3 (30.0%) 2 (18.9%) 2 (2.0%) 2 (30%) 3 (17.1%) 2 (3.8%) 0 (0%) 4 (61.0%) 6 (17.7%) 0 (0%) Median OS (wks) 271 65 31 16 61.1 28 24 11.3 156.6 45.4 13

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