scholarly journals The pattern of prostate cancer local recurrence after radiation and salvage cryoablation

2013 ◽  
Vol 5 (6) ◽  
pp. 125 ◽  
Author(s):  
Chee Kwan Ng ◽  
Naji J. Touma ◽  
Venu Chalasani ◽  
Madeleine Moussa ◽  
Donal B. Downey ◽  
...  
Keyword(s):  
Local Recurrence ◽  
Prognostic Value ◽  
Cox Regression ◽  
Disease Free Survival ◽  
Free Survival ◽  
Prostate Biopsies ◽  
Before And After ◽  
The Impact ◽  
Disease Free

Objective: We assessed the pattern of local recurrence after salvagecryoablation of the prostate, and the impact of local recurrence onintermediate-term outcome.Methods: One hundred twenty-two patients who underwentsalvage cryoablation were studied after a mean follow-up of 56months. Serial prostate biopsy was carried out after cryoablation.The histopathology of prostate biopsies before and after cryoablationwere compared. The prognostic value of post-cryoablationbiopsy was assessed with the Cox regression method.Results: 23.1% of patients had a positive biopsy for prostate cancerfollowing salvage cryoablation. Most cancer recurrences occurredin the apex (51.5%), base (21.2%) and seminal vesicles (18.2%).The presence of cancer at the base of the prostate was found tobe a prognostic factor for eventual biochemical failure. Overall5-year biochemical disease-free survival (bDFS) was 28%, howeverpatients with cancer at the base of the prostate had a 5-yearbDFS of 0%.Conclusion: Cancer recurrences occurred in areas where aggressivefreezing was avoided as it might result in serious problems (e.g.,urethro-rectal fistula and incontinence). Post-cryoablation biopsiesand the location of persistent disease are of prognostic value.

Pituitary surgery as alternative to dopamine agonists treatment for microprolactinomas, a cohort study

2021 ◽  
Author(s):  
Bertrand Baussart ◽  
Chiara Villa ◽  
Anne Jouinot ◽  
Marie-Laure Raffin-Sanson ◽  
Luc Foubert ◽  
...  
Keyword(s):  
Dopamine Agonists ◽  
Cox Regression ◽  
Disease Free Survival ◽  
Pituitary Surgery ◽  
Cerebrospinal Fluid Leakage ◽  
Neurosurgical Department ◽  
Free Survival ◽  
Kaplan Meier ◽  
Disease Free

Objective: Microprolactinomas are currently treated with dopamine agonists. Outcome information on microprolactinoma patients treated by surgery is limited. This study reports the first large series of consecutive non-invasive microprolactinoma patients treated by pituitary surgery and evaluates the efficiency and safety of this treatment. Design: Follow-up of a cohort of consecutive patients treated by surgery. Methods: Between January 2008 and October 2020, 114 adult patients with pure microprolactinomas were operated on in a single tertiary expert neurosurgical department, using an endoscopic endonasal transsphenoidal approach. Eligible patients were presenting a microprolactinoma with no obvious cavernous invasion on MRI. Prolactin was assayed before and after surgery. Disease-free survival was modeled using Kaplan-Meier representation. A cox regression model was used to predict remission. Results: Median follow-up was 18.2 months (range: 2.8 to 155). In this cohort, 14/114 (12%) patients were not cured by surgery, including 10 early surgical failures, and 4 late relapses occurring 37.4 months (33 to 41.8) after surgery. From Kaplan Meier estimates, 1-year and 5-year disease free survival were 90.9% (95% CI, 85.6%-96.4%) and 81% (95% CI,71.2%-92.1%) respectively. The preoperative prolactinemia was the only significant preoperative predictive factor for remission (P<0.05). No severe complication was reported, with no anterior pituitary deficiency after surgery, one diabetes insipidus, and one postoperative cerebrospinal fluid leakage properly treated by muscle plasty. Conclusions: In well selected microprolactinoma patients, pituitary surgery performed by an expert neurosurgical team is a valid first-line alternative treatment to dopamine agonists.

Can CRM status on MRI predict survival in locally advanced rectal cancers: Experience from the Indian subcontinent.

2017 ◽  
Vol 35 (15_suppl) ◽  
pp. e15167-e15167
Author(s):  
Jay Rashmi Anam ◽  
Mihir Chandarana ◽  
Supreeta Arya ◽  
Ashwin Luis Desouza ◽  
Vikas S. Ostwal ◽  
...  
Keyword(s):  
Overall Survival ◽  
Local Recurrence ◽  
Predictive Value ◽  
Locally Advanced ◽  
Disease Free Survival ◽  
Free Survival ◽  
Mri Scans ◽  
Rectal Cancers ◽  
The Impact ◽  
Disease Free

e15167 Background: Neoadjuvant chemoradiation has become the standard approach for treatment of locally advanced rectal cancers. Magnetic Resonence Imaging (MRI) is the staging modality of choice in rectal carcinoma. Recent reports have studied the impact of MRI on local recurrence and survival both in treatment naïve and post treatment settings Methods: A retrospective analysis of prospective database was performed over a period of 1 year. All pretreatment patients with carcinoma of rectum were included in the study. The status of CRM on MRI was compared to that on the histopathology and as a predictor of recurrence and survival. For analysis, the MRI scans done for patients at presentation were labeled as MRIT. This included all patients irrespective of further treatment received. Patients who were treated with NACTRT had two MRI scans. The MRI at presentation in this subset of patients was labeled as MRI1 and the reassessment MRI after NACTRT was labeled as MRI2. Thus, MRI1 represented a subset of MRIT with locally advanced tumors treated with NACTRT. All the sets of MRI scans were analyzed separately for prediction of CRM involvement and for their effect on local recurrence and survival rates. Results: 221 patients were included with a median follow-up 30 months. Sensitivity, specificity, positive predictive value, negative predictive value and accuracy of MRIT, MRI1 and MRI2 to predict CRM status were 50%, 62.3%, 96.5%, 5.6% and 61.8%, 50%, 55%, 95%, 6% and 54.7% and 77.8%, 63.7%, 98%, 11%, 64.5% respectively. On multivariate analysis pathological positive margins alone predicted a poor overall survival (OS) whereas involved CRM on pathology and pretreatment MRI predicted poorer disease free survival and OS Conclusions: CRM status on pathology remains the most important prognostic factor to impact overall survival, disease free survival and local recurrence. CRM status on MRI at presentation alone has significant impact on disease free survival and local recurrence. Although MRI done after neoadjuvant treatment may not predict survival, it has a role in helping modify the surgical approach with a goal to achieve a negative CRM on pathology.

Assessment of the treatment results in patients with breast cancer coexisting with pregnancy: A single-center observational study.

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. e12566-e12566
Author(s):  
Anna Skrzypczyk-Ostaszewicz ◽  
Agnieszka I. Jagiello-Gruszfeld ◽  
Jerzy Giermek ◽  
Zbigniew Nowecki
Keyword(s):  
Breast Cancer ◽  
Overall Survival ◽  
Cancer Diagnosis ◽  
Disease Free Survival ◽  
Breast Cancer Diagnosis ◽  
Diagnosis And Treatment ◽  
Free Survival ◽  
The Impact ◽  
Disease Free

e12566 Background: This study discusses the analysis of the prospectively collected material on pregnant patients treated for breast cancer at the Department of Breast Cancer and Reconstructive Surgery of the Maria Skłodowska-Curie National Oncology Institute - National Research Institute (until 2020: Oncology Center - Institute) in Warsaw, in the years 1995 - 2020. 84 patients were included into the final analysis and 72 children were assessed simultaneously. Methods: The paper summarizes information on the diagnosis and treatment of breast cancer during pregnancy, the course of pregnancy and childbirth and the birth parameters of children i.e. weight, length and Apgar score, as well as the dependencies between them, mainly the impact of some breast cancer, diagnosis and treatment process features on the newborns. The patietnt’s survavial - DFS ( disease free survival) and OS ( overall survival) - was also analyzed. The course of breast cancer diagnosis and treatment data were obtained from the patients’ medical documentation (medical records) and from information provided by the mothers during follow-up visits and read in the children's health books. In order to answer the research questions, statistical analyzes were conducted using the IBM SPSS Statistics 26 package. Results: In the analyzed period, the disease recurrence was recognized in 34 (40.5%) patients, and 24 (28.6%) patients died. The median disease-free survival (DFS) was 12.3 years (147.5 months), and the median overall survival (OS) was not reached during the follow-up period. The estimated 5-year survival rates for DFS and OS were 57.9% and 74.5% respectively, and for 10-year survival - 51.4% and 64.5%. The study showed a statistically significant relationship between the baseline clinical advancement and DFS. It has been also analyzed how the diagnosis, treatment and method of pregnancy termination changed in two time periods (1995-2012 and 2013-2020). There were no statistically significant differences in survival - both DFS and OS - between the group of patients treated before and after 2012. In the assessment of the impact of some factors on the birth children parameters (weight and length), statistically significant results were obtained for: pregnancy advancement at diagnosis, breast cancer stage at diagnosis, pregnancy advancement at the start of chemotherapy, the chemotherapy regimen (classic or dose-dense), the number of cycles of chemotherapy given during pregnancy, and the number of drugs used in supportive treatment. Conclusions: The entire analysis has become not only an insightful characteristic of the studied group, but also these results may be important in everyday clinical practice and may help to optimize the management of an extremely complex and difficult situation, which is the coexistence of pregnancy with a malignant disease that threatens the mother’s life.

BiovaxID™ Vaccine Therapy of Follicular Lymphoma in First Remission: Long-Term Follow-Up of a Phase II Trial and Status of a Controlled, Randomized Phase III Trial.

Blood ◽  
2005 ◽  
Vol 106 (11) ◽  
pp. 2441-2441 ◽  
Author(s):  
Carlos Santos ◽  
Lee Stern ◽  
Laura Katz ◽  
Thelma Watson ◽  
Gause Barry
Keyword(s):  
Clinical Trial ◽  
Phase Ii ◽  
Disease Free Survival ◽  
T Cell Response ◽  
Phase Iii ◽  
Patient Specific ◽  
Free Survival ◽  
The Impact ◽  
Disease Free

Abstract Malignant B-cells in Follicular Non-Hodgkin’s Lymphoma expresses a clonal idiotype immunoglobulin which can serve as the basis for a patient-specific anti-idiotype vaccine. In a previous single-arm Phase II study by Bendandi, et al (Nature Med5:1171–1177, 1999), we evaluated the ability of tumor-specific idiotype (Id) conjugated to keyhole limpet hemocyanin (KLH) administered concurrently with granulocyte-monocyte colony-stimulating factor (GM-CSF) adjuvant to induce complete remissions and molecular remissions in treated patients. The vaccine formulation induced a tumor-specific cytotoxic CD8+ and CD4+ T-cell response in patients in first complete remission after standard chemotherapy, as well as achieved molecular remissions in 8 of 11 of these patients. Data available at the time of this abstract for the 20-patient cohort, indicates a median follow-up of 9.167 years. 9 patients (45 %) remain in continuous first CR at their most recent follow-up (either in 2004 or 2005), and overall survival is 95%. The data further indicates the median disease free survival for the cohort is 96.5 months (8.04 years). To date there have been no additional reported mortalities in this cohort. As of August 2005, we report the progress of the Phase III clinical trial for this vaccine, opened in January 2000 by the NCI to evaluate the impact of this hybridoma-based Id vaccine on disease-free survival in a group of up to 375 previously untreated patients who have attained a CR or CRu from PACE [Prednisone, Doxorubicin, Cyclophosphamide, and Etoposide (ProMACE without methotrexate)] chemotherapy, and who are randomized to receive either vaccine or control. To date, 187 patients have been accrued onto the study. Of those patients, 145 (77.5%) achieved a CR or Cru and are being followed in this ongoing clinical trial.

The Effect of Chemotherapy Shortage in Iraq during the United Nations (UN) Sanctions on Outcome of Children with Acute Lymphocytic Leukemia (ALL).

Blood ◽  
2006 ◽  
Vol 108 (11) ◽  
pp. 3317-3317
Author(s):  
Haydar Frangoul ◽  
Mazin F. Al-Jadiry ◽  
Yu Shyr ◽  
Bashar Shakhtour ◽  
Salma A. Al-Hadad
Keyword(s):  
Regression Model ◽  
Cox Regression ◽  
Disease Free Survival ◽  
Dose Intensity ◽  
Diagnostic Tools ◽  
Cox Regression Model ◽  
Free Survival ◽  
Chemotherapy Drugs ◽  
Disease Free

Abstract There was an increase in childhood mortality in Iraq following the UN sanctions in 1990. The sanctions created a widespread shortage of medications, particularly chemotherapy drugs. We examined the effect of chemotherapy shortage on outcome of ALL in Iraqi children. Between 1990 and 2002, 670 children with ALL were treated at Children Welfare Teaching Hospital in Baghdad. Detailed records were available for review, including documentation of missed doses of chemotherapy and reason(s) for missing it. Excluded from the analysis were patients who refused or discontinued therapy or were lost to follow up prior to the completion of therapy. ALL risk classification analysis was based on the NCI risk grouping; children were treated per the UKALL X and XI (1990–1997) and MRC 97 (1998–2002) protocols. Therapy consisted of 4 phases: induction, consolidation/interim maintenance, intensification and maintenance. Drug shortage was defined as decrease or elimination of medication solely due to unavailability of medication, and not due to myelosuppression or other toxicities. Because compliance with oral medications is subjective, our analysis was limited to intravenous medication during the first 3 phases of therapy. A Cox regression model was used to examine variables associated with outcome. There were 413 patients with standard risk (SR) disease with a median age of 4.9 years (range 1.08–9.83) and median presenting WBC of 9050 (range 400–47000), and 257 with high risk disease (HR) with a median age of 8 years (range 1.3–15) and median presenting WBC of 79300 (range 800–600000). Diagnosis of ALL was based on microscopic examination and cytochemical stains; cytogenetics and flow cytometry were not available. The median follow up for all patients is 4.8 years. For SR patients the disease free survival (DFS) and survival at 5 years are 63% and 68% respectively. In Cox regression model SR patients who received ≤ 50% of prescribed chemotherapy during induction had a significantly worse DFS (RR 0.494, 95% CI 0.30 to 0.814; p=0.0058). For HR patients the disease free survival (DFS) and survival at 5 years are 49% and 53% respectively. For HR patients those who received ≤ 50% of prescribed chemotherapy during consolidation/interim maintenance had a significantly worse DFS (RR 0.45, 95% CI 0.2018 to 1.0253; p= 0.057). Overall survival (OS) of patients who did not miss any chemotherapy due to shortage in the first 3 phases of therapy was superior in both SR (85% vs. 63%, p=0.0038) and HR patients (72% vs. 49% p= 0.018) at 5 years. The OS of children who received all chemotherapy was significantly better than those who missed any chemotherapy due to shortage at 5 years (81% vs. 58%) (p=0.0002). Despite the limited supportive care and diagnostic tools during the UN sanctions, Iraqi children who were able to receive all their intravenous chemotherapy had comparable outcome to that described in developed countries. These results suggest that dose intensity of chemotherapy is most important during induction for SR patients and during consolidation/interim maintenance therapy for HR patients.

scholarly journals The Prognostic Significance of the Preoperative Full Blood Count after Resection of Colorectal Liver Metastases

HPB Surgery ◽  
2009 ◽  
Vol 2009 ◽  
pp. 1-8 ◽  
Author(s):  
K. Dajani ◽  
D. A. O'Reilly ◽  
N. De Liguori Carino ◽  
P. Ghaneh ◽  
G. Poston ◽  
...  
Keyword(s):  
Risk Factors ◽  
Platelet Count ◽  
Cox Regression ◽  
Prognostic Significance ◽  
Disease Free Survival ◽  
Haematological Parameters ◽  
Full Blood Count ◽  
Free Survival ◽  
The Impact ◽  
Disease Free

Introduction. Increased preoperative platelet and neutrophil counts are risk factors for decreased survival in several different malignancies. Our aim was to investigate the relationship between overall or disease-free survival after resection of CRLM and the preoperative haematological parameters. Methods. We reviewed a cohort of 140 patients who underwent resection of CRLM with curative intent, utilising prospectively maintained databases. Patient demographics, operative details, FBC, CRP, INR, histopathology results, and survival data were examined. Kaplan-Meier survival and Cox regression analyses were used to determine the impact of all variables on survival. Results. 140 patients (96 males) with a median age of 67 years (range 33–82 years) underwent resection of CRLM. A significant correlation was exhibited between preoperative platelet count and neutrophil count (rho = 0.186, ). When modelled as continuous covariates in a Cox regression hazards, an increased preoperative platelet () and neutrophil counts () were significantly associated with overall survival. Of the haematological parameters assessed only preoperative platelet count showed a strong trend of association with disease free survival; however this failed to reach statistical significance (). Conclusions. Increased preoperative platelet and neutrophil counts are independent risk factors for decreased survival in patients undergoing resection of CRLM in our series of patients. These findings require validation in larger studies to determine their relationship with survival. Further research into the role of these cell types in tumour progression, particularly in the development and inhibition of angiogenesis, is warranted.

scholarly journals Local recurrence and five year survival after abdominoprineal resection of the rectum due to the rectal carcinoma

2002 ◽  
Vol 49 (2) ◽  
pp. 19-22 ◽  
Author(s):  
Zoran Krivokapic ◽  
Goran Barisic ◽  
V. Markovic ◽  
Milos Popovic ◽  
Sladjan Antic ◽  
...  
Keyword(s):  
Local Recurrence ◽  
Rectal Carcinoma ◽  
Disease Free Survival ◽  
Free Survival ◽  
Cumulative Survival ◽  
Significant Difference ◽  
Distant Spread ◽  
Disease Free ◽  
Dukes C

In the period 01.01.1991 - 12.31.1996, 523 operations due to rectal carcinoma were performed on the First Surgical Clinic, the Third Department for Colorectal Surgery. Most common localization of tumor was in the distal third of the rectum 65,2%. In the middle third, there were 28,9% and in the upper, intraperitoneal third 5,9%. We performed 286 low anterior stapled resections, 93 anterior resections with hand-sewn anastomosis and 144 Abdominoperineal excisions of rectum (Miles procedure). Pathohistological examination revealed adenocarcinoma in all cases. In this study we analyzed local recurrence and five-year survival after long-term follow-up in the group where Miles procedure was carried out as a potentially curative procedure (except 4,9% cased with Dukes D stage). There were 74,3% males and 23,7% females median age 59,2 years. According to Dukes classification there were 4,9% in stage A, 47,2% in stage B, 43,1% stage C, and 4,9% stage D. There were 4 (2,7%) postoperative deaths. Recurrence of the disease was registered in 44 (30,5%) patients. Local recurrence alone was found in 14 (9,7%) patients, while distant spread was registered in 30 (20,8%) patients. At present, the median follow-up is at 72,9 months. Analysis by the Kaplan-Meier's test shows cumulative survival of 61%, and disease free survival of 63,4% at 60 months of the follow-up. Dukes C is associated with a very poor prognosis; sur-M\al after 60 months of follow up shows cumulative Survival of 0,35 while Dukes B has far better prognosis (0,86). Analysis of disease free survival by Dukes stage shows that Dukes C has the worst prognosis (disease free survival 0,36 after 60 months), while stage B has much better prognosis (0,84). Local recurrence analysis by the Kaplan-Meier's test shows disease free survival of 84,9% at 60 months of follow-up. Analysis of local recurrence by Dukes stage shows 1,00% disease free survival for cases in stage A, 0,94 for Dukes B and 0,66 for Dukes C, while overall comparison between groups regarding local recurrence using the Wilcoxon (Gehan) statistic shows statistically significant difference (p=0,005). There is no statistical difference between Dukes A and Dukes B cases in distribution of local recurrence.

MART-1 Is Expressed Less Frequently on Circulating Melanoma Cells in Patients Who Develop Distant Compared With Locoregional Metastases

1999 ◽  
Vol 17 (8) ◽  
pp. 2562-2562 ◽  
Author(s):  
Benjamin J. Curry ◽  
Kieda Myers ◽  
Peter Hersey
Keyword(s):  
Prognostic Significance ◽  
Disease Free Survival ◽  
Melanoma Cells ◽  
Surgical Removal ◽  
Free Survival ◽  
Before And After ◽  
Localized Disease ◽  
Polymerase Chain ◽  
Disease Free

PURPOSE: Polymerase chain reaction (PCR) with tyrosinase and with MART-1 permits detection of small numbers of circulating melanoma cells (CMCs) in patients who have undergone surgical resection of localized disease. In a previous study, we showed that PCR with MART-1 had sensitivity and specificity similar to those of PCR with tyrosinase in terms of detection of CMCs but that PCR with MART-1 seemed to identify a different but overlapping subgroup of patients. In the current study, we examined the utility and prognostic significance of PCR with tyrosinase and with MART-1. PATIENTS AND METHODS: We analyzed the prognostic significance of the patterns of expression of tyrosinase and MART-1 in 186 patients followed sequentially before and after surgical removal of American Joint Committee on Cancer stage I, II, or III melanoma. RESULTS: PCR with tyrosinase and with MART-1 in the first 3 months after surgery identified 68.5% of 73 patients who developed recurrence in the 2-year period after surgery. Approximately 35% of patients with positive tests remained disease-free at 2-year follow-up. We found that patients with disseminated recurrence had a significantly lower incidence of MART-1–positive CMCs (16%) than of tyrosinase-positive CMCs (63%). Patients with locoregional metastases had CMCs that expressed tyrosinase and MART-1 at similar rates. These differences in expression of the markers in patients with disseminated recurrence were also associated with a much lower disease-free survival, in those who had CMCs that were positive for tyrosinase but negative for MART-1. The reverse applied in those with locoregional disease. CONCLUSION: These findings suggest that PCR with MART-1 and with tyrosinase identifies subgroups of patients who develop disseminated or locally recurrent metastases. We hypothesize that immune responses against MART-1 may reduce the establishment of disseminated metastases.

Allogeneic Transplantation for Adult Acute Lymphoblastic Leukemia (ALL) with Rituximab or Campath I-H.

Blood ◽  
2004 ◽  
Vol 104 (11) ◽  
pp. 5132-5132
Author(s):  
Issa F. Khouri ◽  
Rima M. Saliba ◽  
Partow Kebriaei ◽  
Carrie Ma ◽  
Cindy Ippoliti ◽  
...  
Keyword(s):  
Median Time ◽  
Acute Gvhd ◽  
Disease Free Survival ◽  
Disease Status ◽  
Allogeneic Transplantation ◽  
Study Group ◽  
Free Survival ◽  
The Impact ◽  
Disease Free

Abstract Because of potential synergy with chemotherapy and non-overlapping toxicity, we investigated the addition of Rituximab or Campath 1-H to the standard myeloablative conditioning regimen of cyclophosphamide (60 mg/kg daily x 2) and total body irradiation (12.0 Gy in four fractions) prior to allogeneic transplantation for ALL. Transplantation was performed on day 0. Rituximab was added if patients’ disease expressed CD20+ &gt; 20% by flow-cytometry. It was administered (375 mg/m2 ) on days −6, −1, +7 and +14. Campath I-H (10 mg daily intravenously, days −6 to −2) was added if patients’ CD20 expression was &lt;20% and CD52 &gt;20%. Thirty-two adult consecutive patients were studied. Eleven were in first remission with poor prognostic features, 11 in 2nd remission, and 10 were ≥ 3rd remission, or in relapse. Twenty-nine patients had B-cell, two had T-cell and one had an undifferentiated phenotyping. The study group included 19 males and 13 females of median age 35 yrs (range, 19–57). Median # of prior chemoregimens received was 2 (range, 1–6). In both groups of patients, prophylaxis for GVHD consisted of a combination of tacrolimus and methotrexate. Pharmacokinetic studies in patients who received Campath I-H showed no detectable level of the antibody one-day prior to- or after the infusion of the donor graft. Median follow-up for survivors was 19 months. Outcomes were: Campath-study group Rituximab-study group P -value Prior Chemoregimens (range) 2(1–6) 2(1–3) 0.04 Donor Type     Matched unrelated 3(28%) 8(38%) 0.2     Matched sibling 7(63%) 12(57%)     Mismatched sibling 1(9%) 1(5%) Cell Source     PB 8(73%) 11(52%) 0.2     Marrow 3(27%) 10(48%) Disease Status     CR1/CR2 5(45%) 17(81%) 0.05     Others 6(55%) 4(19%) Median time ANC &gt;500 13 12 0.07     (range) (11–17) (10–24) Median time Platelets &gt;20K 13 13 0.8     (range) (6 – 31) (7 – 34) Day 100 TRM 0 1(5%) Acute GVHD II–IV (N,% kM) 2 (18%) 5 (24%) 0.7 Acute GVHD III–IV (N, % kM) 0 2 (9%) Chronic extensive GVHD (N, cumulative incidence) 3 (27%) 9 (54%) 0.4 Overall Survival (18 mos) (95% CI) 53% (21 – 77) 52% (26 – 73) 0.9 Disease-free survival (18 mos) (95% CI) 54% (23 – 75) 37% (15 – 60) 0.8 No prognostic factor was found to be of significance for survival, disease-free survival, or relapse. This included: age (&lt;35 vs ≥ 35), source of graft, disease status at transplant, # prior regimens (&lt;2 vs ≥ 2), acute or chronic GVHD, use of Rituximab or Campath. Our results indicate that the addition of Rituximab or Campath I-H in allogeneic transplantation for ALL is safe. There was no delay in engraftment and no added toxicity or risk of mortality. Longer follow-up is needed to evaluate the impact of this strategy upon survival and relapse.

NCIC CTG MA.17: Intent to treat analysis (ITT) of randomized patients after a median follow-up of 54 months

2006 ◽  
Vol 24 (18_suppl) ◽  
pp. 549-549 ◽  
Author(s):  
J. Ingle ◽  
D. Tu ◽  
L. Shepherd ◽  
M. Palmer ◽  
J. Pater ◽  
...  
Keyword(s):  
Cox Regression ◽  
Menopausal Status ◽  
Disease Free Survival ◽  
Rank Test ◽  
Free Survival ◽  
Before And After ◽  
Intent To Treat ◽  
Treat Analysis ◽  
Better Than

549 Background: MA.17 evaluated letrozole (LET) or placebo (PLAC) after 5 years of tamoxifen (Tam) and showed [median follow-up 30 months (mos)] significant improvement in disease-free survival (DFS) for LET [hazard ratio (HR) 0.57, p = 0.00008]. The trial was unblinded and PLAC patients (pts) were offered LET. An ITT analysis of all outcomes, before and after unblinding, based on the original randomization was performed. Methods: A stratified log-rank test was used to compare DFS, distant (D)DFS, overall survival (OS) and incidence of contra-lateral breast cancer (CBC). The Cox regression model used baseline stratification variables and two prespecified factors, menopausal status at the start of Tam and time on Tam. Subgroup analyses for DFS and OS were performed for the two prespecified subsets. All p-values were two-sided Results: 5187 pts were randomized at baseline and, at unblinding, 1655 of 2268 PLAC pts accepted LET. At median follow-up of 54 mos (range,16–86) 363 recurrences or CBC’s (144 LET and 219 PLAC) occurred; 118 LET and 176 PLAC pts had recurrent disease and 26 LET and 43 PLAC pts had CBC. 4 year DFS was 94.3% (LET) and 91.4% (PLAC) (HR 0.64; 95% CI, 0.52 - 0.79; p = 0.00002). Corresponding 4 year DDFS was 96.2% and 94.9% (HR 0.76; 0.58–0.99; p = 0.041). 4 year OS was 95.0% (LET) and 95.1% (PLAC) (HR 1.00; 0.78–1.28; p = 0.99). LET was equally effective in node +ve and -ve pts (i.e., similar HRs) in DFS. OS was not significantly different for LET and PLAC in any subgroup. The annual rate of CBC was 0.29% LET (0.18–0.40) and 0.47% PLAC (0.34–0.61); HR 0.61 (0.38–0.98) p = 0.037. 255 pts had died as of the data cut-off (128 LET and 127 PLAC). Conclusions: In this ITT analysis, pts originally randomized to LET within 3 months of stopping Tam did better than PLAC pts in DFS, DDFS and CBC, despite 73% of PLAC pts crossing to LET after unblinding. This highlights the strong beneficial effect of extended adjuvant therapy with LET. [Table: see text]

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