Durvalumab improves long-term outcome in TNBC: results from the phase II randomized GeparNUEVO study investigating neodjuvant durvalumab in addition to an anthracycline/taxane based neoadjuvant chemotherapy in early triple-negative breast cancer (TNBC).

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. 506-506
Author(s):  
Sibylle Loibl ◽  
Andreas Schneeweiss ◽  
Jens Bodo Huober ◽  
Michael Braun ◽  
Julia Rey ◽  
...  
Keyword(s):  
Neoadjuvant Chemotherapy ◽  
Disease Free Survival ◽  
Tumor Infiltrating Lymphocytes ◽  
Complete Response ◽  
Primary Objective ◽  
Term Outcome ◽  
Long Term Outcome ◽  
Free Survival ◽  
Disease Free

506 Background: The GeparNuevo trial investigated the addition of durvalumab, an anti-PD-L1 checkpoint inhibitor (CPI), to standard neoadjuvant chemotherapy (NACT) in patients with early TNBC. Durvalumab increased the pathological complete response (pCR) rate particularly in patients treated with durvalumab alone before start of chemotherapy (Loibl et al. Ann Oncol 2019). Methods: GeparNuevo randomized patients with cT1b-cT4a-d tumors and centrally confirmed TNBC to durvalumab (D) 1.5 g i.v. or placebo every 4 weeks. D/placebo monotherapy (0.75 g i.v.) was given for the first 2 weeks (window phase), followed by D/placebo plus nab-paclitaxel 125 mg/m² weekly for 12 weeks, followed by D/placebo plus epirubicin/cyclophosphamide (EC) q2 weeks for 4 cycles. Randomization was stratified by stromal tumor infiltrating lymphocytes (sTILs) (low (≤10%), intermediate (11-59%), high (≥60%)). The primary objective was pCR (ypT0 ypN0). Secondary time-to-event endpoints included invasive disease-free survival (iDFS), distant disease-free survival (DDFS) and overall survival (OS). Results: A total of 174 patients were enrolled between June 2016 and September 2017. The pCR rate with durvalumab was 53.4% versus placebo 44.2% (OR 1.45, 95% CI 0.80–2.63, unadjusted Wald p = 0.224). Durvalumab effect was seen only in the window cohort (pCR 61.0% versus 41.4%, OR 2.22, 95% CI 1.06–4.64, p = 0.035; interaction p = 0.048). After a median follow-up of 42.2 months, 34 events occurred in 174 patients. 3-year iDFS in pCR vs non pCR was 92.0% vs 71.9% (log-rank p = 0.002). 3-year iDFS was 84.9% with durvalumab vs 76.9% with placebo (HR 0.54, 95%CI 0.27-1.09, stratified log-rank p = 0.0559); 3-year DDFS 91.4% vs 79.5% (HR 0.37, 95%CI 0.15-0.87, p = 0.0148); 3-year OS 95.1% vs 83.1% (HR 0.26, 95%CI 0.09-0.79, p = 0.0076). No difference was seen in iDFS, DDFS and OS between the window and no window cohort. Conclusions: Durvalumab added to neoadjuvant chemotherapy in TNBC significantly improved long-term outcome despite a small pCR increase and no continuation after surgery. It needs to be questioned whether adjuvant therapy with CPI is needed at all. Clinical trial information: NCT02685059.

De-Intensification of the Chemotherapy Did Not Affect the Outcome of Ph-Positive Acute Lymphocytic Leukemia Patients in the Era of Tyrosine Kinase Inhibitors

Blood ◽  
2016 ◽  
Vol 128 (22) ◽  
pp. 2805-2805
Author(s):  
Olga A. Gavrilina ◽  
Elena N. Parovichnikova ◽  
Vera V. Troitskaya ◽  
Andrey N. Sokolov ◽  
Larisa A. Kuzmina ◽  
...  
Keyword(s):  
Complete Remission ◽  
Acute Lymphocytic Leukemia ◽  
Kinase Inhibitors ◽  
Disease Free Survival ◽  
Lymphocytic Leukemia ◽  
Term Outcome ◽  
Long Term Outcome ◽  
Free Survival ◽  
Disease Free

Abstract Introduction. For more than a decade it's postulated that the addition oftyrosine kinase inhibitors (TKI) to chemotherapy has dramatically improved the long term outcome in Ph-positive adult acute lymphoblastic leukemia (Ph+ ALL). Nevertheless whether do we need chemotherapy at all and if yes - how intensive it should be, is still the matter of debates. The only randomized trial addressing this issue (GRAAL, Blood 2015, 125: 3711-3719) has demonstrated the lack of benefit of more intensive induction at all checkpoints: complete remission (CR) rate, major molecular complete remission (MMolCR), molecular complete remission (MolCR), progression disease (PD) and resistance. We have conducted two consecutive trials in Ph+ ALL aiming to evaluate the efficacy of more and less intensive chemotherapy approach in combination with constant non-stop 600 mg Imatinib application. Aim. Toanalyze of the protocol RALL-2009 with ITK and RALL-Ph+-2012 effectiveness in patients with Ph+ ALL. The primary objective was the major molecular complete remission (MMolCR) rate after induction (70th day), patients being then eligible for allogeneic stem cell transplantation (SCT) if they had a donor, or autologous SCT if in MMolR and no donor. Patients and methods. Since Jan 2010 till July 2016, 120 new cases of ALL were verified in our National Research Center for Hematology with 68 (56,7%) of them being B-cell precursors ALL and 25 diagnosed as Ph-positive (36,8%). Since 2010 till 2012, 10 Ph+ ALL pts (median age 35 years (19-68), m/f (50%)/(50%), CNS disease=1, WBC> 30*109/l=5(50%), bcr/abl transcript p190/p210/p190+210 6(60%)/3(30%)/1(10%)) were treated according to RALL-2009 protocol (ClinicalTrials.gov public site; NCT01193933) with parallel Imatinib. This protocol includes 8 cytostatic drugs and no intervals between treatment phases. Since 2012 till now 15 other pts (median age 40 years (17-61); m/f 7(46,7%)/8(53,3%); CNS disease=1, WBC>30*109/l=5(33,3%), bcr/abl transcript p190/p210/p190+210 9(60%)/5(33%)/1(7%)) were included in RALL- Ph+-2012 protocol, based mainly on 600 mg Imatinib with prednisolone, VNCR, L-asp, followed by 6-MP and MTX. Both protocols suggested the shift to Dasatinib (100-140 mg) after non-achievement of MolCR at day 70 of treatment. MolCR was stated if no bcr/abl chimeric transcript was detected by PCR with 10-4 sensitivity. All patients were considered as candidates for allogeneic HSCT if HLA-identical donor was available. Results. At day 70th disregarding the chemotherapy intensity there was 40% of MolCR on both protocols (RALL-2009 - n=4 and RALL-2012 - n=6). No death within 2 months of induction/consolidation were registered on less intensive protocol in comparison with 2 cases on RALL-2009. Hematological CR was achieved in all pts (except two early deaths on RALL-2009) - 23 of 25 (92%). There was one autologous HSCT in older pts, included in RALL-2012 (n=3, aGVHD and severe infections, at a median +4 months after HSCT and more than 12 months of CR duration). The 3y OS, DFS and relapse probability (RP) for all 25 pts constituted 37,8%, 32,5% and 52,1% (Fig. 1). The long-term outcome on both protocols (RALL-2009 and RALL-2012) was similar: OS - 45% vs 27,7% (p=0,27), DFS - 45% vs 22,1% (p=0,94), RP - 35,7% vs 57% (p=0,29), respectively (Fig.2). Conclusion. De-intensification of the chemotherapy does not affect the effectiveness of the therapy Ph-positive acute lymphocytic leukemia in era of the tyrosine kinase inhibitors. We haven't seen differences in achievement of molecular remission when we deescalated chemotherapy (40% vs. 40%). However, when we reduced toxicity of the chemotherapy in ALL-2012 protocol, we were able to realize more extra allo-BMT and it could improve long-term results of the therapy Ph+ ALL. Figure Overall, disease-free survival and relapse probability in patients with Ph+ ALL on RALL protocols. Figure. Overall, disease-free survival and relapse probability in patients with Ph+ ALL on RALL protocols. Figure Overall, disease-free survival and relapse probability in patients with Ph+ ALL on RALL-2009 and RALL-2012 protocols. Figure. Overall, disease-free survival and relapse probability in patients with Ph+ ALL on RALL-2009 and RALL-2012 protocols. Disclosures No relevant conflicts of interest to declare.

Early Mortality of Newly Diagnosed Adult Acute Promyelocytic Leukemia Treated with the AIDA Protocol.

Blood ◽  
2005 ◽  
Vol 106 (11) ◽  
pp. 4617-4617
Author(s):  
George Gortzolidis ◽  
Athanasios Zomas ◽  
Theodore Marinakis ◽  
Evridiki Michalis ◽  
Athanasios Galanopoulos ◽  
...  
Keyword(s):  
Disease Free Survival ◽  
Early Mortality ◽  
Induction Phase ◽  
Molecular Remission ◽  
Term Outcome ◽  
Long Term Outcome ◽  
Free Survival ◽  
The Impact ◽  
Disease Free

Abstract APL represents a particular subtype of acute myeloid leukemia with characteristic clinical features, as well as specific immunophenotypic, cytogenetic and molecular findings owing to the chromosomal translocation t(15;17). Anthracycline-based chemotherapy and All-Trans Retinoid Acid (ATRA) became the cornerstone of APL treatment by improving significantly the long term outcome of patients, even though there is some controversy regarding the impact of this combination on the mortality of the induction phase. Herein, we analysed retrospectively the outcome of 16 consecutive adult APL patients who were diagnosed and treated in our Unit from 12/1998 to 10/2004. The analysis focuses more on the parameters of treatment-related mortality, cause of death and disease-free survival post AIDA chemotherapy. All patients were suffering from the classical form of APL and were homogeneously treated as follows: induction consisted of ATRA p.o. and idarubicin i.v. at conventional doses of 45mg/m2/d, from D1 to CR and 12mg/m2/d, D2,4,6,8 (total of 4 infusions), respectively. Dose modifications for elderly individuals were not allowed. Complete remitters were consolidated with 3 courses of chemotherapy without ATRA, where as non-remitters were taken off protocol and received other therapy. Patients in continuing hematological and molecular remission at the end of consolidation were administered maintenance therapy for 2 years with oral 6-MP at 90mg/m2/d, oral MTX weekly at 15mg/m2 and ATRA for 15 days every 3 months. In all cases, the morphological diagnosis of APL was confirmed by chromosome and immunophenotypic analysis of blasts in addition to molecular studies. The median age of our cohort was 55 years (range 31–78) and the male/female ratio was 12/4. Three patients (3/16, 19%) were ≥ 65 years at diagnosis. Two cases (2/16, 12%) presented with a leukocyte count of ≥10 x 103/mm3 while the median Wbc at presentation was 6.5 x 103/mm3. All cases had either clinical (haemorrhagic) or laboratory evidence of disseminated intravascular coagulation. Six patients (6/16, 37%) deceased during the induction phase from pulmonary bleeding (2 cases,days 8 and 13 respectively), intracerebral bleeding (1 case,day 6), myocardial infarction-cardiac arrest (1 case,day 5), respiratory distress syndrome secondary to ATRA syndrome (1 case, day 17), and sepsis-induced hemophagocytosis syndrome (1 case, day 38). All ten out of the 16 (63%) surviving patients achieved hematological and molecular CR and remain to date relapse-free in excellent clinical condition. The median overall survival and disease-free survival for the whole group is 25 months but the same parameters for the surviving patients is better at 42 months. Our results corroborate that in APL the AIDA protocol together with maintenance treatment is highly effective in producing sustained haematological and molecular remission. Despite this excellent antileukaemic activity, early mortality (37% in our cohort) caused chiefly by fatal bleeding and thrombotic events (four patients) limits considerably patient survival and deserves further research in order to improve long-term outcome.

scholarly journals RHEALITY: Recurrence of HEr2+ pAtients: evaluation of Long term outcome In patients receiving trastuzumab TherapY

2019 ◽  
Author(s):  
Mahasti Saghatchian ◽  
Elsa Curtit ◽  
David Coeffic ◽  
Alain Flinois ◽  
Christelle Levy
Keyword(s):  
Real Life ◽  
Disease Free Survival ◽  
Disease Recurrence ◽  
Nodal Status ◽  
Adjuvant Trastuzumab ◽  
Term Outcome ◽  
Long Term Outcome ◽  
Free Survival ◽  
Disease Free

Abstract Background Despite improved prognosis of HER2+ eBC since the introduction of trastuzumab in the adjuvant setting in 2006, disease recurrences still occur in some patients after a few years. We aimed to describe in real life the long-term follow-up to assess disease-free and metastasis-free survival of patients with HER2+ eBC treated with adjuvant trastuzumab. Methods This was a multicenter, retrospective, cohort study assessing HER2+ eBC patients diagnosed between 2009 and 2010 and treated with adjuvant trastuzumab. Data were collected from patient’s medical charts. Disease-free survival (DFS), and metastatic-free survival (MFS) were evaluated in the overall population and within subgroups according to hormonal and nodal status. Results In the overall population (n=2,513) at 7 years, the DFS rate was 75.8% [95%CI 74.0%-77.6%], and the MFS rate was 84.1% [82.5%-85.6%]. According to hormonal status, the 7-year DFS rate was significantly higher for HR+ than for HR- patients [80.0% vs . 68.6%; p <0.001], and the 7-year MFS rate [87.9% for HR+ vs . 77.5% HR-]. According to nodal status, the 7-year DFS rate was significantly higher for N- than for N+ patients [86.7% vs . 66.4%; p <0.001], and the 7-year MFS rate [94.7% for N- vs . 74.9% for N+]. Conclusions Despite introduction of adjuvant trastuzumab, prognosis of HER2+ eBC is still a matter above all in subgroups associated with a higher risk of disease recurrence. Our real-world study pointed out a particularly aggressive profile of N+ and HR- subgroups and the need for more efficient approaches for these particular group of patients.

scholarly journals Recurrence of HEr2+ pAtients: evaluation of Long term outcome In patients receiving trastuzumab TherapY

2019 ◽  
Author(s):  
Mahasti Saghatchian ◽  
Elsa Curtit ◽  
David Coeffic ◽  
Alain Flinois ◽  
Christelle Levy
Keyword(s):  
Real Life ◽  
Disease Free Survival ◽  
Disease Recurrence ◽  
Nodal Status ◽  
Adjuvant Trastuzumab ◽  
Term Outcome ◽  
Long Term Outcome ◽  
Free Survival ◽  
Disease Free

Abstract Background Despite improved prognosis of HER2+ eBC since the introduction of trastuzumab in the adjuvant setting in 2006, disease recurrences still occur in some patients after a few years. We aimed to describe in real life the long-term follow-up to assess disease-free and metastasis-free survival of patients with HER2+ eBC treated with adjuvant trastuzumab. Methods This was a multicenter, retrospective, cohort study assessing HER2+ eBC patients diagnosed between 2009 and 2010 and treated with adjuvant trastuzumab. Data were collected from patient’s medical charts. Disease-free survival (DFS), and metastatic-free survival (MFS) were evaluated in the overall population and within subgroups according to hormonal and nodal status. Results In the overall population (n=2,311) at 7 years, the DFS rate was 76.3% [95%CI 74.5%-78.2%], and the MFS rate was 84.2% [82.6%-85.8%]. According to hormonal status, the 7-year DFS rate was significantly higher in hormone-receptor positive (HR+) than hormone-negative (HR-) patients [80.5% vs . 69.2%; p <0.001 ], and the 7-year MFS rate [88.0% for HR+ vs . 77.7% HR-]. According to nodal status, the 7-year DFS rate was significantly higher for N- than for N+ patients [87.2% vs . 66.8%; p <0.001], and the 7-year MFS rate [94.7% for N- vs . 74.9% for N+; p <0.001]. Conclusions Despite introduction of adjuvant trastuzumab, prognosis of HER2+ eBC is still a matter above all in subgroups associated with a higher risk of disease recurrence. Our real-world study pointed out a particularly aggressive profile of N+ and HR- subgroups and the need for more efficient approaches for these particular group of patients.

Survival and recurrence of breast cancer patients with pathologic complete response after neoadjuvant chemotherapy.

2019 ◽  
Vol 37 (15_suppl) ◽  
pp. e12121-e12121
Author(s):  
Young Joo Lee ◽  
Sei-Hyun Ahn ◽  
Byung Ho Sohn ◽  
jong Won Lee ◽  
Il Yong Chung ◽  
...  
Keyword(s):  
Neoadjuvant Chemotherapy ◽  
Pathologic Complete Response ◽  
Disease Free Survival ◽  
Complete Response ◽  
Good Prognosis ◽  
Her2 Status ◽  
Nodal Disease ◽  
Ki 67 ◽  
Free Survival ◽  
Disease Free

e12121 Background: Patients with Pathologic complete response after neoadjuvant chemotherapy is known to have a good prognosis. However, there is a difference depending on how the complete remission is defined. Methods: We analyzed basic characteristics and outcomes of 295 patients who had pathologic complete response defined as ypT0 and ypTis after neoadjuvant chemotherapy for breast cancer at Asan Medical Center in Seoul, Korea. Results: Median follow up period was 66.5 month(6~128 month). Overall survival was 94% at 5-year and 10-year. No difference was shown in preoperative age, grade, HR/HER2 status, Ki-67 level. Clinical stage III showed worst outcome(85.8%). Survival rate between ypT0N0 (98.8%) and ypTis (89.1%, p=0.00) and between ypT0/TisN residual (85.7%, p=0.00) was shown, but no statistical difference between ypTis and ypT0/Tis with residual nodes(p=0.539). Disease free survival also showed no statistical significance between age, HR/Her2 status. But patients with low Ki-67 level(0~20%)(68.2%) at diagnosis had worse DFS compared to high Ki-67 level(>20%)(87.5%)(P=0.013). No difference between intrinsic subtypes was shown. Patients with residual nodal disease had worse DFS(66.1%) than ypN0(89.1%)(p=0.00). DFS of ypT0N0 was 92.7% and ypTisN0(75.5%), ypT0/Tis with residual metastatic nodes(71.4%). There was no significant difference in type of chemotherapy regimen. Conclusions: Overall survival and disease free survival was different in ypT0N0 with ypTis and residual nodal disease. Good prognosis of pathologic complete response should be limited to cases in which the cancer has completely disappeared.

Long-Term Follow-Up Analysis of HD9601 Trial Comparing ABVD Versus Stanford V Versus MOPP/EBV/CAD in Patients With Newly Diagnosed Advanced-Stage Hodgkin's Lymphoma: A Study From the Intergruppo Italiano Linfomi

2011 ◽  
Vol 29 (32) ◽  
pp. 4227-4233 ◽  
Author(s):  
Teodoro Chisesi ◽  
Monica Bellei ◽  
Stefano Luminari ◽  
Antonella Montanini ◽  
Luigi Marcheselli ◽  
...  
Keyword(s):  
Hodgkin’S Lymphoma ◽  
Disease Free Survival ◽  
Hodgkin's Lymphoma ◽  
Advanced Stage ◽  
Term Outcome ◽  
Long Term Outcome ◽  
Free Survival ◽  
Significant Difference

Purpose The Intergruppo Italiano Linfomi HD9601 trial compared doxorubicin, bleomycin, vinblastine, and dacarbazine (ABVD) versus doxorubicin, vinblastine, mechloretamine, vincristine, bleomycin, etoposide, and prednisone (Stanford V [StV]) versus the combination of mechlorethamine, vincristine, procarbazine, prednisone (MOPP) with epidoxorubicin, bleomycin, vinblastine (EBV), lomustine, doxorubicin, and vindesine (CAD) (MOPP/EBV/CAD [MEC]) for the initial treatment of advanced-stage Hodgkin's lymphoma to select which regimen would best support a reduced radiotherapy program (limited to two or fewer sites of either previous bulky or partially remitting disease). Superiority of ABVD and MEC to StV was demonstrated. We report analysis of long-term outcome and toxicity. Patients and Methods Patients with stage IIB, III, or IV were randomly assigned among six cycles of ABVD, three cycles of StV, and six cycles of MEC; radiotherapy was administered in 76, 71, and 50 patients in the three arms, respectively. Results Currently, the median follow-up is 86 months; in the prolonged observation period, eight additional failures, including two relapses, both in the StV arm, and six additional deaths in complete response were recorded. The 10-year overall survival rates were 87%, 80%, and 78% for ABVD, MEC, and StV, respectively (P = .4). The 10-year failure-free survival was 75%, 74%, and 49% in the ABVD, MEC, and StV arms, respectively (P < .001). The 10-year disease-free survival of patients treated or not with radiotherapy (RT) showed no difference for ABVD or MEC (85% v 80% and 93% v 68%), and a statistically significant difference for StV (76% v 33%; P = .004). No significant long-term toxicity was recorded. Conclusion The long-term analysis confirmed ABVD and MEC superiority to StV. The use of RT after StV was established as mandatory. ABVD is still to be considered as the standard treatment with a good balance between efficacy and toxicity.

scholarly journals Survival after Curative Resection for Stage I Colorectal Mucinous Adenocarcinoma

2020 ◽  
Author(s):  
Liang Huang ◽  
Shuangling Luo ◽  
Sicong Lai ◽  
Yonghua Cai ◽  
Zhanzhen Liu ◽  
...  
Keyword(s):  
Multivariate Analysis ◽  
Mucinous Adenocarcinoma ◽  
Disease Free Survival ◽  
Stage I ◽  
Prognostic Impact ◽  
Clinicopathologic Characteristics ◽  
Term Outcome ◽  
Long Term Outcome ◽  
Free Survival ◽  
Disease Free

Abstract Background : The prognostic value of the mucinous adenocarcinoma histotype on the early stages especially for stage I colorectal cancer (CRC) is still unclear. This study determined the clinicopathologic characteristics and long-term outcome of stage I colorectal mucinous adenocarcinomas (MAC).Methods : Among the total of 503 patients with stage I CRC (56 having MAC and 447 having non-MAC) who underwent radical resection, the correlation between clinicopathological factors and MAC was analyzed. Multivariate analysis was performed to determine whether mucinous histotype itself was an independent prognostic impact in stage I patients.Results : MACs were observed more frequently located in the colon than rectum ( p =0.046), more frequently displayed the microsatellite instability (MSI) phenotype ( p =0.023) and had a greater frequency of T2 stage ( p =0.001). The rate of recurrence was 13.5% and the cancer-specific mortality was 4.3% among all stage I CRC patients. There was no difference in disease-free survival and overall survival between MACs and non-MACs. On multivariate analysis, older age ( p =0.030), rectal cancer ( p =0.025), lymphovascular invasion (LVI) ( p <0.001), and microsatellite stability (MSS) phenotypes ( p =0.023) were independently associated to poor survival of stage I CRC. A high carcinoembryonic antigen (CEA) level ( p =0.031), LVI ( p =0.002) and MSS phenotypes ( p =0.012) were independently related to short disease-free survival of stage I CRC.Conclusions : Compared with non-MAC, MAC patients had more T2 patients and more MSI phenotypes in stage I CRC at presentation, but the mucinous histology is not a significant predictor of recurrence and prognosis in stage I CRC.

P49 A HIATAL HERNIA >3CM IS ASSOCIATED WITH WORSE RESPONSE TO NEOADJUVANT TREATMENT IN ESOPHAGEAL CANCER PATIENTS

2019 ◽  
Vol 32 (Supplement_2) ◽  
Author(s):  
Mantziari Styliani ◽  
St-Amour Penelope ◽  
Winiker Michael ◽  
Drmain Clarisse ◽  
Godat Sebastien ◽  
...  
Keyword(s):  
Esophageal Cancer ◽  
Cancer Patients ◽  
Hiatal Hernia ◽  
Neoadjuvant Treatment ◽  
Disease Free Survival ◽  
Response Rates ◽  
Complete Response ◽  
Free Survival ◽  
Disease Free

Abstract Aim The aim of this study was to assess whether a preoperative HH≥3cm had an impact on histopathologic tumor response after neoadjuvant treatment, as well as on overall and disease-free survival. Background & Methods Hiatal hernia (HH) and long-term gastroesophageal reflux are known risk factors for esophageal cancer. Previous data suggest a negative impact of large hiatal hernias on survival after esophagectomy, as well as an increased toxicity after neoadjuvant treatment (1), although evidence remains scarce and the mechanism is not fully elucidated. All consecutive patients who underwent surgical esophagectomy for adenocarcinoma or squamous cell cancer of the esophagus and gastro-esophageal junction from 2012-2018 were assessed. Baseline oesogastroduodenoscopy reports and CT-scan images were retrospectively reviewed to identify the presence of a HH of ≥3cm (2). Response to neoadjuvant treatment as assessed by the Mandard score (3), postoperative outcomes and survival were compared between HH and non-HH patients (defined as HH<3cm or no HH at all). Categorical variables were compared with the x2 or Fisher’s test, whereas continuous ones with the Mann-Whitney-U test. The Kaplan-Meier method and log-rank test were used for survival analyses. Results Among the 174 included patients, 44 (25.3%) had a HH≥3cm upon diagnosis. HH patients compared to the non-HH had significantly more Barrett’s metaplasia (52.3% vs 20%, p<0.001), although no differences in baseline stage were observed. HH patients presented a worse response to neoadjuvant treatment compared to non-HH patients (TRG 4-5 in 40.5% vs 21.3%, p=0.033). Among HH patients, perioperative chemotherapy compared to radiochemotherapy showed a trend to higher complete response rates (TRG 1 in 25% vs 11.5%, p=0.059). In the radiochemotherapy subgroup (n=112), HH patients had worse complete response rates than non-HH patients (TRG 1 in 11.5% vs 26.7% respectively, p=0.050). However, no differences in overall or disease-free survival were observed between HH and non-HH patients in the whole cohort or in subgroup analyses. Conclusion A HH≥3cm is frequently encountered in esophageal cancer patients. The presence of HH was associated with worse response to neoadjuvant treatment, especially radiochemotherapy. However, the presence HH did not have an impact on long-term survival and recurrence.

ALFA-9000 Trial - An Analysis of Cytogenetic Subsets: Significant Long-Term Benefit of Early Induction Reinforcement Is Observed in CBF-AML Only.

Blood ◽  
2005 ◽  
Vol 106 (11) ◽  
pp. 1842-1842
Author(s):  
Claude Gardin ◽  
Sylvie Chevret ◽  
Christiane Charrin ◽  
Xavier Thomas ◽  
Christian Bastard ◽  
...  
Keyword(s):  
Disease Free Survival ◽  
Normal Karyotype ◽  
High Dose ◽  
Term Outcome ◽  
Long Term Outcome ◽  
Free Survival ◽  
Early Introduction ◽  
Intermediate Group ◽  
Term Benefit

Abstract We have recently reported the results of the ALFA-9000 randomized trial in which younger adults with AML had a significant better long-term relapse-free interval when receiving a timed-sequentially reinforced induction (arm C) as compared to either standard 3+7 (arm A) or double (arm B) induction (Castaigne et al, Blood 2004). Both arms B and C included the same induction reinforcement with mitoxantrone and intermediate-dose cytarabine (ID-AraC) systematically administered at day 20 in arm B or at day 8 in arm C. Although patients aged between 15 and 65 years were included in this study, the gain in relapse incidence associated with arm C was observed in those less than 50 years of age only. We report here the outcomes of cytogenetic subsets, according to the arm C versus arm A/B stratification. Overall, 405 karyotypes were available (68%) and classified according to the SWOG classification as 56 favorable (CBF-AML, 46/56 under the age of 50 years), 215 intermediate (including 194 normal), 91 unfavorable, and 43 of unknown significance. Outcome of unfavorable and unknown subsets did not differ significantly in C versus A/B. Patients with complex karyotype or chromosome 7, 5q, or 3q abnormalities, as well as those with 11q23 abnormalities, had a similar outcome whatever their induction arm. Similarly, no benefit of early reinforcement was observed in the intermediate group, nor in patients with a normal karyotype even after adjustment on WBC or when considering only those aged less than 50 years. In the favorable subset, patients with either t(8;21) (N=30) or inv(16) (N=26) had identical long-term outcome. Contrary to other subsets, this outcome differed strikingly among induction arms with better disease-free survival in arm C (64% versus 28% at 5 years, P=.05 after adjustment on WBC) with a similar trend observed for event-free survival. The value of higher than standard doses of cytarabine in CBF-AML patients, either during induction or as post-remission therapy, has been demonstrated by several cooperative groups. Our results do suggest that early introduction of ID-AraC is also associated with long-term benefit in this favorable subgroup of patients, even greater when made at day 8 instead of day 20. We will evaluate prospectively this induction approach in the next French Intergroup CBF-AML study, in which all patients will then receive high-dose cytarabine during post-remission therapy.

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