scholarly journals Duration of response after DEB-TACE compared to lipiodol-TACE in HCC-naïve patients: a propensity score matching analysis

2021 ◽  
Author(s):  
Irene Bargellini ◽  
Valentina Lorenzoni ◽  
Giulia Lorenzoni ◽  
Paola Scalise ◽  
Gianni Andreozzi ◽  
...  
Keyword(s):  
Propensity Score ◽  
Tumor Progression ◽  
Tumor Response ◽  
Complete Response ◽  
Tumor Burden ◽  
Local Tumor Control ◽  
Lower Number ◽  
Tumor Control ◽  
Duration Of Response

Abstract Objectives To retrospectively compare long-term outcomes of first-line drug-eluting particle (DEB)- transarterial chemoembolization (TACE) and lipiodol-TACE, in patients with unresectable hepatocellular (HCC). Methods We retrospectively reviewed our database to identify adult patients with treatment-naïve unresectable HCC, who underwent TACE from 2006 to 2013. Patients were excluded in the absence of complete medical records relative to first TACE, 1-month follow-up, and/or sufficient follow-up data. Periprocedural complications, duration of hospitalization, 1-month tumor response by mRECIST, time to tumor progression (TTP) and target tumor progression (TTTP), and overall survival (OS) were evaluated. Results Out of an initial series of 656 patients, 329 patients were excluded for unavailability of sufficient baseline and/or follow-up data. The remaining 327 patients underwent either lipiodol-TACE (n = 160) or DEB-TACE (n = 167). Patients treated with lipiodol-TACE had a significantly higher tumor burden. By propensity score, patients were matched according to baseline differences (BCLC stage, uninodular or multinodular HCC, and unilobar or bilobar HCC), resulting in 101 patients in each treatment group. Lipiodol-TACE was associated with a significantly higher incidence of adverse events (p = 0.03), and longer hospitalization (mean, 2.5 days vs 1.9 days; p = 0.03), while tumor response, TTP, and OS were comparable. In patients achieving 1-month complete response (CR) of target tumor, TTTP was significantly (p = 0.009) longer after DEB-TACE compared to lipiodol-TACE (median, 835 vs 353 days), resulting in a lower number of re-treatments during the entire follow-up (0.75 vs 1.6, p = 0.01). Conclusion Compared to lipiodol-TACE, DEB-TACE offers higher tolerability, reduced hospitalization, and more durable target tumor response after CR. Key Points • Compared to lipiodol-TACE, DEB-TACE is better tolerated and has reduced side effects, which translates into shorter hospitalization. • When complete radiological response according to the mRECIST is obtained 1 month after the procedure, DEB-TACE offers a more durable local tumor control compared to lipiodol-TACE. • In these patients, the longer duration of response after DEB-TACE translates into a lower number of re-interventions.

scholarly journals Efficacy and safety of selective internal radiation therapy with yttrium-90 for the treatment of unresectable hepatocellular carcinoma

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Nguyen Van Thai ◽  
Nguyen Tien Thinh ◽  
Thai Doan Ky ◽  
Mai Hong Bang ◽  
Dinh Truong Giang ◽  
...  
Keyword(s):  
Prognostic Factors ◽  
Proportional Hazards ◽  
Tumor Response ◽  
Complete Response ◽  
Tumor Burden ◽  
Cox Proportional Hazards ◽  
Factors Affecting ◽  
Kaplan Meier ◽  
Modified Recist

Abstract Background This retrospective analysis was undertaken to evaluate the efficiency of SIRT with Y-90 microspheres and determined prognostic factors affecting patients with unresectable HCC. Methods A total of 97 patients diagnosed with unresectable HCC who underwent SIRT with Y-90 microspheres. Patient survival was assessed using the Kaplan–Meier method, and prognostic factors affecting survival were assessed using log-rank tests and Cox proportional hazards regression. Results Among the 97 patients (90 males, mean age 60.4 ± 12.3 years) who underwent SIRT, the median clinical follow-up was 16.4 (1.8–62) months. The median overall survival (OS) was 23.9 ± 2.4 months. Tumor response according to the Modified RECIST in patients followed up beyond 6 months included a complete response (CR) to treatment in 12 patients (18.8%), partial response (PR) in 23 (35.8%), stable disease (SD) in 8 (12.5%), and progressive disease (PD) in 21 (32.8%). Factors associated with longer OS included age > 65 years, BCLC stage B, tumor size < 5 cm, tumor burden < 25%, and tumor response (CR/PR). In multivariate analysis, unilobar disease and objective tumor response (CR/PR) were predictors of longer OS. Conclusion SIRT was an effective treatment for unresectable HCC. Unilobar disease before SIRT and tumor response (CR/PR) were positive prognostic factors.

Gamma Knife surgery combined with resection for treatment of a single brain metastasis: preliminary results

2010 ◽  
Vol 113 (Special_Supplement) ◽  
pp. 90-96 ◽  
Author(s):  
M. Yashar S. Kalani ◽  
Aristotelis S. Filippidis ◽  
Maziyar A. Kalani ◽  
Nader Sanai ◽  
David Brachman ◽  
...  
Keyword(s):  
Survival Data ◽  
Initial Treatment ◽  
Median Survival Time ◽  
Local Tumor Control ◽  
Survival Duration ◽  
Tumor Control ◽  
Local Tumor ◽  
Systemic Control ◽  
Cranial Metastasis

Object Resection and whole-brain radiation therapy (WBRT) have classically been the standard treatment for a single metastasis to the brain. The objective of this study was to evaluate the use of Gamma Knife surgery (GKS) as an alternative to WBRT in patients who had undergone resection and to evaluate patient survival and local tumor control. Methods The authors retrospectively reviewed the charts of 150 patients treated with a combination of stereotactic radiosurgery and resection of a cranial metastasis at their institution between April 1997 and September 2009. Patients who had multiple lesions or underwent both WBRT and GKS were excluded, as were patients for whom survival data beyond the initial treatment were not available. Clinical and imaging follow-up was assessed using notes from clinic visits and MR imaging studies when available. Follow-up data beyond the initial treatment and survival data were available for 68 patients. Results The study included 37 women (54.4%) and 31 men (45.6%) (mean age 60 years, range 28–89 years). In 45 patients (66.2%) there was systemic control of the primary tumor when the cranial metastasis was identified. The median duration between resection and radiosurgery was 15.5 days. The median volume of the treated cavity was 10.35 cm3 (range 0.9–45.4 cm3), and the median dose to the cavity margin was 15 Gy (range 14–30 Gy), delivered to the 50% isodose line (range 50%–76% isodose line). The patients' median preradiosurgery Karnofsky Performance Scale (KPS) score was 90 (range 40–100). During the follow-up period we identified 27 patients (39.7%) with recurrent tumor located either local or distant to the site of treatment. The median time from primary treatment of metastasis to recurrence was 10.6 months. The patients' median length of survival (interval between first treatment of cerebral metastasis and last follow-up) was 13.2 months. For the patient who died during follow-up, the median time from diagnosis of cerebral metastasis to death was 11.5 months. The median duration of survival from diagnosis of the primary cancer to last follow-up was 30.2 months. Patients with a pretreatment KPS score ≥ 90 had a median survival time of 23.2 months, and patients with a pretreatment KPS score < 90 had a median survival time of 10 months (p < 0.008). Systemic control of disease at the time of metastasis was not predictive of increased survival duration, although it did tend to improve survival. Conclusions Although the debate about the ideal form of radiation treatment after resection continues, these findings indicate that GKS combined with surgery offers comparable survival duration and local tumor control to WBRT for patients with a diagnosis of a single metastasis.

scholarly journals Stereotactic radiosurgery for treating meningiomas eligible for complete resection

2021 ◽  
Vol 16 (1) ◽  
Author(s):  
Maximilian I. Ruge ◽  
Juman Tutunji ◽  
Daniel Rueß ◽  
Eren Celik ◽  
Christian Baues ◽  
...  
Keyword(s):  
Adverse Events ◽  
Stereotactic Radiosurgery ◽  
Medical Condition ◽  
Local Tumor Control ◽  
Complete Resection ◽  
Neurological Deficits ◽  
Tumor Control ◽  
Recurrence Rates ◽  
Treatment Volume

Abstract Background For meningiomas, complete resection is recommended as first-line treatment while stereotactic radiosurgery (SRS) is established for meningiomas of smaller size considered inoperable. If the patient´s medical condition or preference excludes surgery, SRS remains a treatment option. We evaluated the efficacy and safety of SRS in a cohort comprising these cases. Methods In this retrospective single-centre analysis we included patients receiving single fraction SRS either by modified LINAC or robotic guidance by Cyberknife for potentially resectable intracranial meningiomas. Treatment-related adverse events as well as local and regional control rates were determined from follow-up imaging and estimated by the Kaplan–Meier method. Results We analyzed 188 patients with 218 meningiomas. The median radiological, and clinical follow-up periods were 51.4 (6.2–289.6) and 55.8 (6.2–300.9) months. The median tumor volume was 4.2 ml (0.1–22), and the mean marginal radiation dose was 13.0 ± 3.1 Gy, with reference to the 80.0 ± 11.2% isodose level. Local recurrence was observed in one case (0.5%) after 239 months. The estimated 2-, 5-, 10- and 15-year regional recurrence rates were 1.5%, 3.0%, 6.6% and 6.6%, respectively. Early adverse events (≤ 6 months after SRS) occurred in 11.2% (CTCEA grade 1–2) and resolved during follow-up in 7.4% of patients, while late adverse events were documented in 14.4% (grade 1–2; one case grade 3). Adverse effects (early and late) were associated with the presence of symptoms or neurological deficits prior to SRS (p < 0.03) and correlated with the treatment volume (p < 0.02). Conclusion In this analysis SRS appears to be an effective treatment for patients with meningiomas eligible for complete resection and provides reliable long-term local tumor control with low rates of mild morbidity.

Radiosurgery for Treatment of Recurrent Intracranial Hemangiopericytomas

Neurosurgery ◽  
2002 ◽  
Vol 51 (4) ◽  
pp. 905-911 ◽  
Author(s):  
Jason Sheehan ◽  
Douglas Kondziolka ◽  
John Flickinger ◽  
L. Dade Lunsford
Keyword(s):  
Stereotactic Radiosurgery ◽  
Survival Rates ◽  
Gamma Knife Radiosurgery ◽  
Residual Tumor ◽  
Local Tumor Control ◽  
Tumor Control ◽  
Local Tumor ◽  
University Of Pittsburgh ◽  
Kaplan Meier

Abstract OBJECTIVE Hemangiopericytomas are highly aggressive meningeal tumors with tendencies for recurrence and metastasis. The purpose of this retrospective, single-institution review was to evaluate the efficacy and role of stereotactic radiosurgery in the management of recurrent hemangiopericytomas. METHODS We reviewed data for patients who underwent stereotactic radiosurgery at the University of Pittsburgh between 1987 and 2001. Fourteen patients underwent radiosurgery for 15 discrete tumors. Prior treatments included transsphenoidal resection (n = 1), craniotomy and resection (n = 27), embolization (n = 1), and conventional radiotherapy (n = 7). Clinical and radiological responses were evaluated. Follow-up periods varied from 5 to 76 months (mean, 31.3 mo; median, 21 mo). The mean radiation dose to the tumor margin was 15 Gy. RESULTS Seventy-nine percent of patients (11 of 14 patients) with recurrent hemangiopericytomas demonstrated local tumor control after radiosurgery. Twelve of 15 tumors (i.e., 80%) dramatically decreased in size on follow-up imaging scans. Regional intracranial recurrences were retreated with radiosurgery for two patients (i.e., 15%); neither of those two patients experienced long-term tumor control. Local recurrences occurred 12 to 75 months (median, 21 mo) after radiosurgery. Local tumor control and survival rates at 5 years after radiosurgery were 76 and 100%, respectively (Kaplan-Meier method). We could not correlate prior irradiation or tumor size with tumor control. Twenty-nine percent of the patients (4 of 14 patients) developed remote metastases. Radiosurgery did not seem to offer protection against the development of intra- or extracranial metastases. CONCLUSION Gamma knife radiosurgery provided local tumor control for 80% of recurrent hemangiopericytomas. When residual tumor is identified after resection or radiotherapy, early radiosurgery should be considered as a feasible treatment modality. Despite local tumor control, patients are still at risk for distant metastasis. Diligent clinical and radiological follow-up monitoring is necessary.

Linear Accelerator Radiosurgery for Nonvestibular Schwannomas

Neurosurgery ◽  
2011 ◽  
Vol 68 (4) ◽  
pp. 974-984 ◽  
Author(s):  
Matthew M. Kimball ◽  
Kelly D. Foote ◽  
Frank J. Bova ◽  
Yueh-Yun Chi ◽  
William A. Friedman
Keyword(s):  
Surgical Resection ◽  
Cranial Nerve ◽  
Linear Accelerator ◽  
Jugular Foramen ◽  
Symptomatic Improvement ◽  
Local Tumor Control ◽  
Tumor Control ◽  
High Morbidity ◽  
Local Tumor

Abstract BACKGROUND: Nonvestibular schwannomas are uncommon tumors of the brain often treated by surgical resection. Surgery may be associated with high morbidity. OBJECTIVE: We present a series of nonvestibular schwannomas treated with linear accelerator radiosurgery during a 19-year period. METHODS: This is a retrospective analysis of patients who underwent treatment of nonvestibular schwannomas at the University of Florida with linear accelerator radiosurgery between August 1989 and February 2008. Forty-nine patients underwent treatment during the study period, and 6 were lost to follow up. The mean age was 51 years (range, 17-82 years), 39% had previous surgical resection, and 67% presented with preradiosurgery cranial nerve deficits. There were 25 trigeminal, 18 jugular foramen, 2 facial, 2 oculomotor, 1 hypoglossal, and 1 high cervical schwannomas. The median tumor volume was 5.3 mL (range, 0.3-24.5 mL), treated with a median dose of 1250 cGy (range, 1000-1500 cGy). Study endpoints were actuarial local tumor control and neurological outcome. RESULTS: Forty-three patients were available for a median follow-up of 37 months (range, 6-210 months). Actuarial local tumor control was 97% at 1 year, 91% at 4.5 years, and 83% at 5 years. There were 4 new cranial nerve deficits (9%) including facial numbness (2 patients), anesthesia dolorosa (1 patient), and facial weakness (1 patient). Thirty-nine percent had documented clinical and/or symptomatic improvement. There were no other morbidity and no mortality with treatment. CONCLUSION: Radiosurgery for nonvestibular schwannomas offers good actuarial local tumor control and has superior morbidity compared with surgical resection. This is the largest linear accelerator radiosurgical series, and the second largest radiosurgical series reported to date.

Updated outcomes with axicabtagene ciloleucel (axi-cel) retreatment (reTx) in patients (pts) with relapsed/refractory (R/R) indolent non-Hodgkin lymphoma (iNHL) in ZUMA-5.

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. 7548-7548
Author(s):  
Julio C. Chavez ◽  
Caron A. Jacobson ◽  
Alison Sehgal ◽  
Sattva Swarup Neelapu ◽  
David G. Maloney ◽  
...  
Keyword(s):  
T Cell ◽  
Neutralizing Antibodies ◽  
Complete Response ◽  
Tumor Burden ◽  
Primary Analysis ◽  
T Cell Therapy ◽  
Car T Cell ◽  
Car T ◽  
Grade 3

7548 Background: ZUMA-5 is a Phase 2 study of axi-cel anti-CD19 CAR T-cell therapy in pts with R/R iNHL (follicular lymphoma [FL]; marginal zone lymphoma [MZL]). In the primary analysis, 11 pts (9 FL; 2 MZL) were retreated with axi-cel, achieving an overall response rate (ORR) of 100% (91% complete response [CR] rate) at a median follow-up of 2.3 mo post-reTx, with no Grade ≥3 cytokine release syndrome (CRS) or neurologic events (NEs; Chavez et al. ASH 2020. #2036). Here, we report updated clinical and translational outcomes with longer follow-up in pts retreated with axi-cel in ZUMA-5. Methods: Eligible pts with FL or MZL had R/R disease after ≥2 lines of therapy. Pts were considered for reTx if they progressed after a response at mo 3, had no evidence of CD19-negative relapse in biopsy, had no axi-cel neutralizing antibodies, and had no Grade 4 CRS or NEs with 1st Tx. Retreatment was per investigator discretion. At both Txs, pts received axi-cel (2×106 CAR T cells/kg) after conditioning chemotherapy. Results: As of 9/14/2020, 13 pts with iNHL (11 FL; 2 MZL) received axi-cel reTx, with 2 pts retreated after the primary analysis. Before their 1st Tx, pts had median 4 prior lines of therapy; 85% had stage 3–4 disease; 82% had FLIPI of ≥3; 46% were POD24; 77% had refractory disease. Among the 13 retreated pts, 85% had a CR to 1st Tx. Median 1st duration of response (DOR) was 8.2 mo. Detectable CD19 was confirmed in all evaluable biopsies from retreated pts at relapse, and median time from 1st Tx to reTx was 10.6 mo. Following reTx, the ORR was 100% (77% CR rate). After a median follow-up of 11.4 mo, the median DOR had not yet been reached; 46% of retreated pts had ongoing responses at data cutoff. At 1st Tx, CRS occurred in 9 pts (5 Grade 1, 4 Grade 2); NEs occurred in 5 (3 Grade 1, 1 Grade 2, 1 Grade 3). At reTx, CRS occurred in 8 pts (6 Grade 1, 2 Grade 2); NEs occurred in 4 (3 Grade 1, 1 Grade 2). Median peak levels of biomarkers typically associated with severe CRS and NEs were similar at reTx and 1st Tx (IL-6, 7.7 vs 5.7 pg/mL; IL-2, 1.8 vs 0.9 pg/mL; IFN-γ, 62.9 vs 64.2 pg/mL). In the 11 retreated pts with FL, tumor burden (median sum of product diameters [SPD]) was lower before reTx vs 1st Tx (1416 vs 4770 mm2). Engraftment index (CAR T-cell expansion relative to SPD) is an indirect proxy for effector:target ratio and a key covariate of response to axi-cel (Locke et al. Blood Adv. 2020). Though median peak CAR T-cell levels appeared lower at reTx vs 1st Tx (5.2 vs 14.3 CAR+ cells/µL blood), engraftment index was similar (0.003 vs 0.005 cells/µL×mm2). Conclusions: Axi-cel reTx achieved deep and durable responses, with an acceptable safety profile. Tumor CD19 positivity was maintained at relapse, and engraftment index was similar at both Txs, comparing favorably to previous reports in aggressive lymphomas (Locke et al. ASCO 2020. #8012). These data suggest axi-cel reTx is a promising option for pts with R/R iNHL. Clinical trial information: NCT03105336.

scholarly journals Volumetric changes and clinical outcome for petroclival meningiomas after primary treatment with Gamma Knife radiosurgery

2018 ◽  
Vol 129 (6) ◽  
pp. 1623-1629 ◽  
Author(s):  
Zjiwar H. A. Sadik ◽  
Suan Te Lie ◽  
Sieger Leenstra ◽  
Patrick E. J. Hanssens
Keyword(s):  
Gamma Knife ◽  
Clinical Symptoms ◽  
Cranial Nerves ◽  
Gamma Knife Radiosurgery ◽  
Local Tumor Control ◽  
Tumor Control ◽  
Local Tumor ◽  
Tumor Control Rate ◽  
Petroclival Meningiomas

OBJECTIVEPetroclival meningiomas (PCMs) can cause devastating clinical symptoms due to mass effect on cranial nerves (CNs); thus, patients harboring these tumors need treatment. Many neurosurgeons advocate for microsurgery because removal of the tumor can provide relief or result in symptom disappearance. Gamma Knife radiosurgery (GKRS) is often an alternative for surgery because it can cause tumor shrinkage with improvement of symptoms. This study evaluates qualitative volumetric changes of PCM after primary GKRS and its impact on clinical symptoms.METHODSThe authors performed a retrospective study of patients with PCM who underwent primary GKRS between 2003 and 2015 at the Gamma Knife Center of the Elisabeth-Tweesteden Hospital in Tilburg, the Netherlands. This study yields 53 patients. In this study the authors concentrate on qualitative volumetric tumor changes, local tumor control rate, and the effect of the treatment on trigeminal neuralgia (TN).RESULTSLocal tumor control was 98% at 5 years and 93% at 7 years (Kaplan-Meier estimates). More than 90% of the tumors showed regression in volume during the first 5 years. The mean volumetric tumor decrease was 21.2%, 27.1%, and 31% at 1, 3, and 6 years of follow-up, respectively. Improvement in TN was achieved in 61%, 67%, and 70% of the cases at 1, 2, and 3 years of follow-up, respectively. This was associated with a mean volumetric tumor decrease of 25% at the 1-year follow-up to 32% at the 3-year follow-up.CONCLUSIONSGKRS for PCMs yields a high tumor control rate with a low incidence of neurological deficits. Many patients with TN due to PCM experienced improvement in TN after radiosurgery. GKRS achieves significant volumetric tumor decrease in the first years of follow-up and thereafter.

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.

A Combination of Rituxan, Cyclophosphamide and Dexamethasone (RCD) Results in Long-Lasting Responses in Autoimmune Anemia and Thrombocytopenia in CLL Patients: A Single Institution Study.

Blood ◽  
2006 ◽  
Vol 108 (11) ◽  
pp. 2832-2832
Author(s):  
Matthew S. Kaufman ◽  
Yehuda Z. Lebowicz ◽  
Nancy Driscoll ◽  
Christina Johnson ◽  
Dale Janson ◽  
...  
Keyword(s):  
Response Duration ◽  
Initial Response ◽  
Tumor Burden ◽  
Post Treatment ◽  
Lymphocytic Leukemia ◽  
First Episode ◽  
Available N ◽  
Duration Of Response ◽  
Autoimmune Processes

Abstract Coombs positive hemolytic anemia (AIHA) and idiopathic thrombocytopenic purpura (ITP) are well-known complications of chronic lymphocytic leukemia(CLL). Both are autoimmune phenomena thought to be byproducts of the immune system dysregulation manifested in patients with CLL. Rituxan, cyclophosphamide and dexamethasone(RCD) are known to effectively target lymphocytes and inhibit autoimmune processes. We present our data analyzing 18 CLL patients with one or both of these autoimmune processes treated with the RCD regimen between 1998 and 3/2006. These patients consisted of 15 with AIHA alone, 2 with both AIHA and ITP and one with ITP alone. The RCD cycle consisted of rituximab 375mg/m2 iv infusion given on day 1, cyclophosphamide 750–1000mg/m2 iv (depending on CLL tumor burden) on day 2, and dexamethasone 12 mg iv on days 1 and 2, and orally days 3 through 7. These cycles were repeated at intervals of 3–4 weeks, depending upon recovery of blood counts. All 18 patients responded to treatment in terms of hgb, platelets or both. For the first episodes of AIHA (n=17) mean starting hgb was 8.1g/dL (range 4.0–12.1) and mean post-treatment hgb was 13.2 g/dL(range 10.0–15.4)(Table 1). The three patients with ITP had a platelet increase from nadirs of 1,000, 1,000 and 14,000 to 408,000, 161,000 and 135,000, respectively. Mean duration of initial response was 22 months (range 6–41). Nine patients relapsed and were retreated with RCD. Again, all 9 responded, and had a mean increase in hgb of 5.1g/dL (range 1.4–7.7) with a mean duration of second response of 16 months(range 3–33). Overall, median survival from initiation of RCD was 70 months (95% CI; 46 to an upper limit not-yet determinable, with follow-up to 8/2006). Of 8 patients with post-treatment Coombs data available for the first episode of AIHA, 4 (50%) converted to Coombs negativity (Table2) and had a mean duration of response of 23.0 months (range 12–41) vs 8.8 months for those who did not convert(range 6–11). In all AIHA episodes (including repeat episodes) with post-treatment Coombs data available (n=18), 6 of 18 (33%) converted to Coombs negativity. The mean duration of response was 19.8 months (range 6–41) for all episodes with conversion to Coombs negativity, vs 7.0 months for those without(range 3–12). This finding that Coombs conversion portends a longer duration of response suggests treatment goals for AIHA should be a conversion to Coombs negative, and not stopped with recovery of hgb. Table 1. Hemoglobin response to RCD N Mean Std Deviation Min Hgb Max Hgb at start episode 1 17 8.1 g/dL 2.1 4.0 g/dL 12.1 g/dL Hgb at end episode 1 17 13.2 g/dL 1.4 10.0 g/dL 15.4 g/dL Hgb delta episode 1 17 5.1 g/dL 2.3 1.7 g/dL 10.2 g/dL Hgb at start episode 2 9 8.4 g/dL 2.3 5.3 g/dL 12.2 g/dL Hgb at end episode 2 9 13.5 g/dL 1.4 12.3 g/dL 16.6 g/dL Hgb delta episode 2 9 5.1 g/dL 2.1 1.4 g/dL 7.7 g/dL Table 2. Post-treatment Coombs status and response duration N Mean duration of response (in months) Post-treatment Coombs negativity in episode 1 4 22.2 (range 12-41) Post-treatment Coombs positivity in episode 1 4 8.8 (range 6-11) Post-treatment Coombs negativity in all episodes 6 19.8 (range 6-41) Post-treatment Coombs positivity in all episodes 12 7.1 (range 3-12)

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