Four Years of Follow-Up of 1027 Patients with Late Chronic Phase (L-CP), Accelerated Phase (AP), or Blast Crisis (BC) Chronic Myeloid Leukemia (CML) Treated with Imatinib in Three Large Phase II Trials.

Blood ◽  
2004 ◽  
Vol 104 (11) ◽  
pp. 23-23 ◽  
Author(s):  
Richard T. Silver ◽  
Moshe Talpaz ◽  
Charles L. Sawyers ◽  
Brian J. Druker ◽  
Andreas Hochhaus ◽  
...  
Keyword(s):  
Phase Ii ◽  
Chronic Phase ◽  
Progression Free Survival ◽  
Cytogenetic Response ◽  
Imatinib Treatment ◽  
Phase Ii Trials ◽  
Free Survival ◽  
Phase Ii Studies ◽  
Large Phase

Abstract Background This report updates the results of 3 large phase II studies of the orally available BCR-ABL tyrosine kinase inhibitor imatinib for patients (pts) in AP, BC and late chronic phase (L-CP) CML failing prior interferon therapy (Kantarjan et al, ASH 2003; Talpaz et al, ASH 2003). Methods Between August 1999 and June 2000, 1027 pts were enrolled in phase II trials for CML in L-CP (n=532), AP (n=235) or BC (n=260). Pts in L-CP were treated with 400 mg/day and pts in AP or BC with either 400 or 600 mg/day. Dose escalation up to 800 mg/d was allowed in the late-chronic phase study. Pts with a confirmed diagnosis of AP (n=181), BC (n=229) and late-chronic phase (n=454) were evaluated for efficacy. All pts were evaluated for safety. The median time from initial diagnosis to study entry was 32 months for L-CP pts. Results As of 31-Jul-03, 5% patients with BC, 25% of CML-AP and 64% of L-CP patients still remain on treatment. At the recommended dose of 600 mg, an estimated 40% (AP) and 7% (BC) of patients remained progression-free at 36 months, and an estimated 55% (AP) and 14% (BC) patients were alive at 36 months after initiation of imatinib. The 3-year survival rates for pts with AP with a major cytogenetic response at 3 months were 85% vs. 52% for pts with no response (p<0.001). In L-CP patients with a median follow-up of 40 months, 65% of patients achieved a major cytogenetic response, which was complete in 52%. The cytogenetic responses were durable with an estimated 82% of the pts in continuos major cytogenetic response at 3 years. The estimated rates of progression-free survival and overall survival at 3 years were 80% and 88%. Pts with at least a minor cytogenetic response at 6 months ≤65% Ph+ cells) had an estimated 3-year survival rate of 96% vs. 86% for pts with a ( minimal response and 81% for pts with no cytogenetic response (p<0.001). Conclusion In large phase II studies, continuous imatinib treatment is safe and has improved progression-free survival of patients at all stages of CML. Responses to imatinib are durable and are predictive of long-term outcomes. These results will be further updated at the meeting using a data base lock planned for 20-Sept-04 (using data collected up to 31-July-04, i.e. more than 4 years after the last pts enrollment).

The Frequency of Detection of BCR-ABL Mutations in Imatinib Treated Patients with Chronic Phase CML Who Attain a Complete Cytogenetic Response (CCR) Does Not Diminish with Increasing Duration of CCR but the Associated Loss of Response Is Usually Gradual.

Blood ◽  
2004 ◽  
Vol 104 (11) ◽  
pp. 271-271
Author(s):  
Susan Branford ◽  
Z. Rudzki ◽  
A. Grigg ◽  
J. Seymour ◽  
P. Browett ◽  
...  
Keyword(s):  
Early Stage ◽  
Blast Crisis ◽  
Chronic Phase ◽  
Progression Free Survival ◽  
Cytogenetic Response ◽  
Free Survival ◽  
Loss Of Response ◽  
Gradual Loss ◽  
Complete Hematologic Response

Abstract The majority of patients with chronic phase (CP) CML treated with imatinib achieve a CCR, which is associated with a high progression-free survival (PFS). Nevertheless, BCR-ABL mutations have been observed in patients in ongoing CCR. We previously reported that virtually all patients with mutations develop evidence of resistance. The current analysis of 211 patients with CP CML aimed to determine the incidence of mutations in those who achieve CCR, assess whether the incidence varies with increasing duration of CCR, and evaluate the rate of loss of response in those who do develop mutations. BCR-ABL levels measured by quantitative RT-PCR at 1–6 month intervals were used to guide the frequency of mutation analysis. All patients were screened for mutations at least 6 monthly. Of the 211 patients, 159 (75%) achieved CCR after a median of 3 months (25th to 75th percentile 3–6 months), and were then followed for a median of 12 months after achieving CCR (25th to 75th percentile 6–28 months). Twelve patients lost CCR and this was associated with the development of a mutation in 8 (67%). The median time to loss of CCR was 3 months after the mutation was detected (range 1–10 months). Three of these 12 patients proceeded to transplant, and 9 received an increased imatinib dose (4 maintaining a major cytogenetic response (MCR); 3 re-establishing CCR). Only 1 of the 12 lost a complete hematologic response (CHR) (patient had 2 mutations) and none have progressed to blast crisis (BC) with a median follow-up of 9 months (range 6–38 months) including 3 patients with P-loop mutations, which have been associated with a poorer prognosis. As well as the 8 patients who lost CCR after a mutation was detected, mutations were detected in 3 patients who have maintained CCR; 2 had an increased imatinib dose. The detection of a mutation was associated with a rise in the BCR-ABL level in all patients with mutations. Of the 159 patients in CCR, mutations were detected in 11 of 25 (44%) with a &gt;2-fold rise in BCR-ABL whereas none of 131 patients with stable or decreasing BCR-ABL had a mutation detected (P&lt;0.0001). The probability of developing a mutation by 24 months after achieving CCR was 12% (95% CI 4–20%). The risk of developing a mutation did not vary with time during CCR, with 6.7% (95% CI 2.1–11.3%) during the first 12 months of CCR, and 6.0% (95% CI 0–12.8%) during the second 12 months (P=0.8). Patients who had a mutation detected while in CCR still had a favorable PFS (defined as sustained MCR/CHR and lack of evolution to accelerated phase/BC) of 90%, 15 months after the mutation was detected. Patients were censored at time of transplant. This relatively favorable outcome may be related to the rapid response in terms of dose intensification. In conclusion, BCR-ABL mutations may still be detected in patients with a low burden of CML and this risk does not appear to diminish up to 24 months in CCR. We observed a gradual loss of response in patients who did develop a mutation in CCR and none have yet progressed to BC. Thus we recommend that patients in CCR should be closely monitored with regular QPCR studies. Such a policy will usually identify patients with emerging resistance at an early stage and facilitate appropriate therapeutic intervention before disease progression.

Evaluation of the Imatinib Treatment of Patients with Chronic Myeloid Leukemia (CML). a Retrospective Study from Algerian Working Group on CML (GAT-LMC)

Blood ◽  
2016 ◽  
Vol 128 (22) ◽  
pp. 5454-5454
Author(s):  
K Djouadi ◽  
A Bouchakour ◽  
S Taoussi ◽  
MT Abad ◽  
Z Ouchenane ◽  
...  
Keyword(s):  
Overall Survival ◽  
Myeloid Leukemia ◽  
Chronic Phase ◽  
Progression Free Survival ◽  
Molecular Response ◽  
Imatinib Treatment ◽  
Free Survival ◽  
Sokal Score ◽  
Eutos Score

Abstract Introduction: The advent of anti-tyrosine kinase has revolutionized the treatment of chronic myeloid leukemia. Indeed, from 2000, the IMATINIB has become internationally the gold standard of treatment for CML chronic phase, while the allogeneic bone marrow transplant was previously, the 1st intention choice, when an HLA-matched donor is available. The aim of this study is to evaluate the efficiency and the toxicity of a treatment with Imatinib(copy), drug used in Algeria to treat patients with a CML chronic phase. The main objective is to evaluate the overall survival and the progression-free survival to these patients. Materials and methods: This is a longitudinal study, National, multicenter, retrospective, which included Algerian patients with chronic phase CML and treated with Imatinib between January 2007 and December 2013. A technical form was established and distributed to different hematology services nationwide, to collect and analysis the following data: Patient's general characteristics, disease circumstances of discovery, clinical and para-clinical examinations at diagnosis (blood count, blood smear, bone marrow aspiration, karyotype, molecular biology, Sokal prognostic classification score and Eutos score). The treatment: Imatinib 400 mg / d, a therapeutic assessment is made according to the ELN recommendations adapted to our conditions and capabilities in Algeria: The complete hematologic response (CHR) at 03 months and molecular response and / or cytogenetic and / or Fish at 03, 06.12, 18.24 months and more according to capabilities. At 03mois and / or 6 months we search a bcr / abl rate <10%. At 12 months we research a major molecular response (MMR), defined by a bcr / abl ratio lower than 0, 1% according to the ELN. A ratio between 0.1 to 1% is considered a good response according to GAT-LMC (the CML study Algerian group) so the Imatinib treatment is continued. The median follow-up of patients in December 2014 is 48 months (12-84 months). Overall survival and progression-free survival are determined by using the Kaplan-Meier method. The descriptive analysis of the quantitative variables by calculating averages, medians and the qualitative variables, by using percentages and 95% confidence interval. The Chi2 test is used to compare between two variables. Results: From 1024 collated sheets, 1007 are assessable; the median age of patients was 45.7 years (06-87 years), it's about 516 men and 491 women with a sex ratio M / F 1.05. The Diagnosis of CML is done by cytogenetic examination in 337 patients (33%), by Fish 214 patients (21%) and by molecular biology in 401 patients (39%). The prognostic classification (PC), according to the Sokal score, found a low risk in 18.7%, 55.5% as intermediate and a high risk in 25.8%. The Eutos score is less than 87 in 97% and more than 87 in 03%. A CHR at 03mois was found in 907 patients (90.1%). There is no correlation between the RHC at 03 months and the SOKAL PC (p = 0.23), by cons we found a significant correlation with the Eutos score (p <10-3). Molecular assessment at 03 and 06 months is performed in 222 patients and a bcr / abl ratio <10% was found in 66.5%. A molecular evaluation at 12 months showed an MMR in 55.4%. Cytogenetic evaluation (FISH) has found a 28.6% CCyR at 3 months, 45% at 6 months, 64.2% at 12 months (IRIS = 68%), 75.7% at 18 months (IRIS = 76.2%) and 85% at 24 months. Overall survival was 84% at 08 years and it is significantly correlated to Sokal score (p <10-6). A failure to TRT was found in 11.5% of the cases and a 10, 1% relapse rate, related to non-adherence to TRT in 50% of the cases and a lack of monitoring by a regular molecular control in the other half of the cases. Event-free survival at 08 years was 76%. A good clinical and biological tolerance is noted in 90% of the cases. Only 8% of patients were switched to a 2nd generation TKIs because of intolerance. A non-adherence to TRT was found in 14.4%. Conclusion: Imatinib, used in Algeria, is a very interesting molecule both efficiency side and tolerance level. However, we must ensure a molecular monitoring for a patients optimal follow up, and an adequate patient education for a better adherence. Disclosures No relevant conflicts of interest to declare.

Imatinib Is Effective in Children With Previously Untreated Chronic Myelogenous Leukemia in Early Chronic Phase: Results of the French National Phase IV Trial

2011 ◽  
Vol 29 (20) ◽  
pp. 2827-2832 ◽  
Author(s):  
Frédéric Millot ◽  
André Baruchel ◽  
Joelle Guilhot ◽  
Arnaud Petit ◽  
Thierry Leblanc ◽  
...  
Keyword(s):  
Prospective Trial ◽  
Chronic Phase ◽  
Progression Free Survival ◽  
Standard Of Care ◽  
Cytogenetic Response ◽  
Myelogenous Leukemia ◽  
Molecular Response ◽  
Newly Diagnosed ◽  
Free Survival

Purpose Imatinib is the standard of care in adults with chronic myeloid leukemia (CML) in chronic phase (CP). Only a few studies to assess efficacy in children have been performed. We report on the results of the French prospective trial (ClinicalTrials.gov identifier NCT00845221) conducted in children and adolescents with newly diagnosed CML in CP. Patients and Methods A total of 44 patients from age 10 months to 17 years with newly diagnosed CML in CP received daily imatinib 260 mg/m2. Progression-free survival, responses, and tolerance were evaluated. Results With a median follow-up times of 31 months (range, 11 to 64 months), the estimated progression-free survival rate at 36 months was 98% (95% CI, 85% to 100%). A complete hematologic response was achieved in 98% of the patients. The rates of complete cytogenetic response (CCyR) and major molecular response (MMR) were 61% and 31% at 12 months, respectively. During follow-up, CCyR and MMR were achieved in 36 children (77%) and 25 children (57%), respectively. Overall, 30% of the patients discontinued imatinib, mainly because of unsatisfactory response. The most common adverse events were neutropenia and musculoskeletal events. Conclusion Imatinib is effective in children with CML in CP with response rates similar to rates reported in adults. The adverse effects are acceptable, but longer follow-up studies are required to fully assess the long-term impact.

Long-Term Outcome of Imatinib Treatment in Chronic Myeloid Leukemia (CML) Patients in Shanghai: An International Patient Assistance Programs (GIPAP) Analysis.

Blood ◽  
2009 ◽  
Vol 114 (22) ◽  
pp. 4275-4275
Author(s):  
Ai-hua Wang ◽  
Li Zhou ◽  
Yu Zheng ◽  
Jun-min Li ◽  
Zhi-Xiang Shen ◽  
...  
Keyword(s):  
Progression Free Survival ◽  
Cytogenetic Response ◽  
Initial Therapy ◽  
Imatinib Treatment ◽  
Long Term Outcome ◽  
Free Survival ◽  
Optimal Response ◽  
Assistance Programs ◽  
Patient Assistance

Abstract Abstract 4275 Imatinib as an oral Bcr-Abl tyrosine kinase inhibitor is approved as first-line therapy for patients with CML chronic phase (CP), accelerated phase (AP) and blast crisis (BC). As the appointed clinical center for the International Patient Assistance Programs (GIPAP) program, a total of 339 CML patients with CML-CP (n=274), AP (n=30) and BC (n=35) were registered and received imatinib treatment in our center. The starting dose of Imatinib treatment was 400mg daily and dose escalation to 600mg was allowed in patients of CML-AP or BC and in patients who failed to obtained optimal response. All patients were evaluated regularly according to the GIPAP protocol. In this study, we analysed the outcome of Imatinib treatment in these patients in terms of cytogenetic response, overall and progression-free survival and adverse events. The median age was 42 (13-81) years old. The median time from diagnosis to imatinib therapy was 4.4 (0-273) months. The median follow-up was 29 (3-103) months. The overall survival for patients received Imatinib treatment were 92.8±3.1%, 57.3+11.3% and 12.3±9.7% for CML-CP, AP and BC respectively. Among patients with CML-CP, the cumulative complete cytogenetic response (CCyR) were 71.9% at 12 months and 79.9% at the censored follow-up timepoint. In prognosis analysis, there were two major impact factors associated with progression-free survival (PFS) for the CML-CP patients: achievement of CcyR and Imatinib as initial therapy. The estimated 60 month PFS was 87.1±3.7% for patients who achieved a CCyR irrespective of time and only 46.7±1.37% for patients who failed to obtain a CCyR (P<0.0001). For those patients who received imatinib as initial therapy (95.6±1.85%) had a significantly superior PFS than those patients received imatinib as secondary treatment after initial interferon therapy either due to intolerance or failed to obtain optimal response (65.9±6.4%, P<0.0001). Overall Imatinib was well tolerated and no patient switched to other treatment due to toxicity of Imatinib treatment. Overall, Imatinib as initial treatment for CML-CP was effective and safe in the first analysis of GIPAP program in Shanghai. Disclosures: No relevant conflicts of interest to declare.

Correlation of Different Responses to Imatinib on Survival of Patients (pts) with Chronic Myelogenous Leukemia (CML) in Accelerated (AP) and Blast Phase (BP).

Blood ◽  
2005 ◽  
Vol 106 (11) ◽  
pp. 1103-1103 ◽  
Author(s):  
Etsuko Aoki ◽  
Hagop Kantarjian ◽  
Susan O’Brien ◽  
Mary Beth Rios ◽  
Farhad Ravandi ◽  
...  
Keyword(s):  
Chronic Phase ◽  
Progression Free Survival ◽  
Cytogenetic Response ◽  
Survival Advantage ◽  
Myelogenous Leukemia ◽  
P Value ◽  
Blast Phase ◽  
Free Survival ◽  
Best Response

Abstract Imatinib has remarkable activity in CML in all phases, with high rates of hematologic and cytogenetic response. However, in AP and BP responses are frequently less than complete hematologic remission (CHR), including partial hematologic remission (PHR) and return to chronic phase (second CP). The objective of this study was to investigate whether different responses to imatinib conferred a survival advantage in pts with CML in AP and BP. We evaluated 214 pts in AP and 76 pts in BP (11 lymphoid, 63 myeloid, 2 unclassified) treated with imatinib. Median age for AP pts was 49 yrs (range: 22–82 yrs) and for BP, 54 yrs (19–75 yrs). With a median follow-up of 49 months (1.9–67.5 months), 82 (38%) AP and 66 (87%) BP pts have died. A CHR and major cytogenetic (CG) response (MCR) have been achieved in 87% and 53% of AP pts, and 37% and 14% of BP pts, respectively. For AP pts the median overall survival (OS) and progression free survival (PFS) were 65 and 49 months, respectively. In BP pts, median OS and PFS were 7 and 3 months. The OS by best response to imatinib was as follows: Response No. (%) Median OS (months) p value Median PFS (months) p value CG CR=complete CG response (Ph=0%), CG PR=partial CG response (Ph&lt;35%), CG minor=minor CG response (Ph=35–95%), Marrow CR/PR=marrow complete/partial response Accelerated phase CG CR 96 (45) Not reached &lt;0.0001 Not reached &lt;0.0001 CG PR 13 (6) 43 28 CG minor 13 (6) 48 31 CHR 57 (27) 34 22 PHR 16 (7) 14 6 Resistant 11 (5) 5 3 Blast Phase CG CR 6 (8) Not reached &lt;0.0001 Not reached &lt;0.0001 CG PR + minor 8 (11) 12 5 CHR + PHR 12 (16) 13 11 Second CP 6 (8) 9 4 Marrow CR/PR 9 (12) 5 4 Resistant 25 (33) 4 2 We conclude that although cytogenetic responses confer the most survival advantage in AP and BP after imatinib therapy, hematologic responses are associated with a survival benefit.

An Increasing Role for Trabectedin in Gynecological Cancers: Efficacy in Uterine Sarcomas

2011 ◽  
Vol 21 (Supp 1) ◽  
pp. S3-S5 ◽  
Author(s):  
Isabelle Ray-Coquard
Keyword(s):  
Phase Ii ◽  
Progression Free Survival ◽  
Uterine Leiomyosarcoma ◽  
Uterine Sarcomas ◽  
Free Survival ◽  
Phase Ii Studies ◽  
Prospective Phase ◽  
Pretreated Patients ◽  
To Receive ◽  
A Current

Trabectedin is indicated for patients with advanced soft tissue sarcoma after failure of treatment with anthracyclines and ifosfamide or for patients who are unsuited to receive these agents. The agent has shown activity in patients with advanced uterine leiomyosarcoma, with an acceptable safety profile. Thus, the results of phase II studies have shown that treatment with trabectedin results in 30% progression-free survival at 6 months. More than 50% of these pretreated patients were alive at 1 year. The response rate, progression-free survival, and overall survival compared favorably with other single agents (eg, doxorubicin, ifosfamide, and gemcitabine), with clinical benefit in 50% of patients in second-line treatment. These results are being confirmed in a current prospective phase II study in first-line uterine leiomyosarcoma combining trabectedin with doxorubicin.

Phase II Trial of Weekly Intravenous Gemcitabine With Continuous Infusion Fluorouracil in Patients With Metastatic Renal Cell Cancer

2000 ◽  
Vol 18 (12) ◽  
pp. 2419-2426 ◽  
Author(s):  
Brian I. Rini ◽  
Nicholas J. Vogelzang ◽  
Mary C. Dumas ◽  
James L. Wade ◽  
David A. Taber ◽  
...  
Keyword(s):  
Continuous Infusion ◽  
Phase Ii ◽  
Renal Cell ◽  
Response Rate ◽  
Cell Cancer ◽  
Objective Response ◽  
Progression Free Survival ◽  
Free Survival ◽  
Phase Ii Studies ◽  
Metastatic Rcc

PURPOSE: To determine the clinical response rate of the combination of weekly intravenous (IV) gemcitabine with continuous infusion fluorouracil (5-FU) in patients with metastatic renal cell carcinoma (RCC). PATIENTS AND METHODS: Between June 1998 and February 1999, 41 patients with metastatic RCC were enrolled onto this multi-institutional phase II study of gemcitabine 600 mg/m2 over 30 minutes on days 1, 8, and 15 and 5-FU 150 mg/m2/d via continuous IV infusion through a permanent catheter on days 1 to 21 of a 28-day cycle. Patients had a Cancer and Leukemia Group B performance status of 0 or 1, with a median time since diagnosis of metastatic disease of 10 months (range, 0 to 129 months). Thirty-three patients (80%) had multiple metastatic sites, and 34 patients (83%) had prior chemotherapy or immunotherapy. RESULTS: Of the 39 assessable patients, there were no complete responses but seven partial responses (objective response rate = 17%; 95% confidence interval, 8% to 34%). Five minor responses (25% to 50% decreased tumor size) were also observed. The duration of response for the seven partial responders was 2, 3, 7, 8, 10, 11, and 14 months. Median progression-free survival for the gemcitabine/5-FU group was 28.7 weeks versus 8 weeks for a similar cohort of patients treated on previous phase II studies at the University of Chicago (P = .008). The regimen was well tolerated, with fatigue, mucositis, nausea/vomiting, and grade 2 hematologic toxicities being most common. CONCLUSION: Weekly gemcitabine with continuous infusion 5-FU is an active combination in patients with metastatic RCC. Therapy was well tolerated and produced an improvement in progression-free survival over historical controls.

Association of Hydroxyurea to Imatinib Is Effective in Patients with Chronic Myelogenous Leukemia Resistant to Imatinib Alone.

Blood ◽  
2004 ◽  
Vol 104 (11) ◽  
pp. 4693-4693 ◽  
Author(s):  
Roberto Latagliata ◽  
Massimo Breccia ◽  
Ida Carmosino ◽  
Chiara Sarlo ◽  
Rosa De Cuia ◽  
...  
Keyword(s):  
Chronic Myelogenous Leukemia ◽  
Chronic Phase ◽  
Complete Response ◽  
Cytogenetic Response ◽  
Myelogenous Leukemia ◽  
Hematological Toxicity ◽  
Imatinib Treatment ◽  
Duration Of Response ◽  
Wbc Count

Abstract The introduction of Imatinib in the treatment of Chronic Myelogenous Leukemia (CML) leads to the achievement of Complete Cytogenetic Response (CCR) in about 70% of patients: however, in the remaining 30% of patients there is a persistance of Ph+ cells also after standard (400 mg/day) and increased (600 mg/day) dose of Imatinib. These patients are thus cytogenetically resistant to Imatinib alone and their management is at present unclear. From 11/2002 to 11/2003, 10 patients in chronic phase (6 male and 4 female, median age 52.5 years, range 29 – 68 years) with persistance of 100% Ph+ cells (9 patients) or BCR/ABL + cells (1 patient with Ph- BCR/ABL+ CML at onset) after standard (at least 6 months of treatment) followed by increased dose (at least 3 months of treatment) of Imatinib alone, were considered resistant and added Hydroxyurea (HU) to Imatinib. Seven patients have been pretreated with IFN before Imatinib; median times from diagnosis and from Imatinib treatment to HU addition were 51 months (range 23 – 151) and 14 months (range 10 – 31), respectively. HU was given according to WBC count: patients with WBC < 10 x 109/l started HU at the dose of 1 g/day, patients with WBC > 10 x 109/l at the dose of 1.5 g/day. Imatinib was continued at the same previous dosage (600 mg/day in 6 patients and 400 mg/day in 4 patients who did not tolerate increased dosage for hematological toxicity). Three patients achieved a complete response (2 CCR after 3 and 12 months respectively and 1 molecular complete response after 9 months in the patient Ph- BCR/ABL+ at onset) and 1 patient achieved a partial CR (Ph+ < 33%) after 9 months: the remaining 6 patients were resistant with persistance of 100% Ph+ cells. Toxicity was mild and only 1 patient discontinued for 2 weeks the association due to transient thrombocytopenia: no extra-hematological toxicity has been recorded. After a median follow-up of 14 months (range 20 – 10), 2 patients (1 resistant and 1 after 5 months from the achievement of CCR) evolved in Blastic Phase (BP), 5 patients are in stable chronic phase with 100% Ph+ cells and 3 patients are still in response after 4,6 and 7 months respectively. In conclusion, the association of HU with Imatinib seems capable to induce cytogenetic response in at least one third of patients resistant to Imatinib alone, with minimal toxicity: a longer follow-up and a comparison with other associations is needed to evaluate the quality and duration of response in such group of patients.

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