Updated Results of High-Dose Yttrium 90 (90Y) Ibritumomab Tiuxetan with High-Dose Etoposide (VP-16) and Cyclophosphamide (CY) Followed by Autologous Hematopoietic Cell Transplant (AHSCT) for Poor-Risk or Refractory B-Cell Non-Hodgkin’s Lymphoma.

Blood ◽  
2007 ◽  
Vol 110 (11) ◽  
pp. 1891-1891 ◽  
Author(s):  
Auayporn Nademanee ◽  
Andrew Raubitschek ◽  
Arturo Molina ◽  
Joycelynne Palmer ◽  
Ni-Chun Tsai ◽  
...  
Keyword(s):  
Stem Cells ◽  
Overall Survival ◽  
Disease Free Survival ◽  
High Dose ◽  
Ibritumomab Tiuxetan ◽  
Free Survival ◽  
High Dose Regimen ◽  
Disease Free

Abstract Background: 90Y ibritumomab tiuxetan (Zevalin®) has been shown to be an effective therapy for patients with both follicular lymphoma (FL) and diffuse large B-cell lymphoma (DLBCL). We have previously reported the feasibility of adding high-dose 90Y ibritumomab tiuxetan to high-dose VP-16 and CY followed by AHSCT without additional toxicity. Herein, we reported longer follow-up results of this high-dose regimen. Methods: Patients undergo dosimetry study (day-21) with 5 mCi 111In-ibritumomab tiuxetan following 250 mg/m2of rituximab, followed by 90Y ibritumomab tiuxetan (day-14) to deliver a target dose of 1000 cGy to highest normal organ and then VP-16 (day-4), and CY (day-2). Bone marrow biopsy is done on day-7 to estimate the radiation dose. Stem cells are re-infused when the radiation dose to re-infused stem cells is estimated to be <5 cGy. Results: Between 5/00 and 7/05, 53 patients were enrolled; 11 had an imaging study but did not proceed to treatment due to dosimetry ineligibility (7), progressive disease (2), reaction to 111In-ibritumomab tiuxetan (1) and reaction to rituximab (1). 42 patients (25 M: 17F), median age 51 yrs (range 25–59.6) with FL (n=13), DLBCL (n=20), mantle cell (MCL) (n=8) and transformed lymphoma (n=1) were treated. Disease status at AHSCT: 1stCR/PR=11, ≥2ndCR=13, REL=9 and IF=9. Twenty-three (55%) had prior BM involvement. Median number of prior chemo regimens was 2 (range 1–6). All but two had received rituximab. As part of phase I/II trial, 6 received VP-16 40mg/kg and the rest received 60 mg/kg. The median 90Y ibritumomab tiuxetan dose delivered was 70.8 mCi (range 37–105). The treatment was well tolerated with mucositis and neutropenic fever being the most common acute toxicities. All but one patient engrafted. The median time to reach ANC>500/μl and platelet>20,000/μl was 10 days (range 8–17) and 12.5days (range 8–123), respectively. The transplant-related mortality (TRM) at day 100 was 2%. There were 8 deaths due to relapse (3), second malignancies (2), graft failure (1), alcohol induced liver failure (1) and sudden death (1). Secondary malignancies occurred in 3 (7%) heavily pre-treated FL: pancreatic cancer at 3.8 yrs, acute myeloid leukemia at 5 years and one with abnormal chromosome but without morphologic evidence of MDS at 1 year. At a median follow-up of 55 months (range, 25–84) for the surviving patients, the 4-year estimated overall survival (OS) and disease-free survival (DFS) is 81% (95% CI, 67–89%), and 65% (95% CI, 54–74%), respectively (figure.1). The 4-year estimated DFS for FL, DLBCL and MCL is 71% (95% CI, 51–85%), 67% (95% CI, 49–79%) and 47% (95% CI, 29–63%), respectively. Conclusion: Our long-term results suggest that the combination of high-dose 90Y ibritumomab tiuxetan and high-dose VP-16 and CY is an effective high-dose regimen, especially for FL and DLBCL. Short term toxicities appear comparable to other conventional high-dose regimens. Further prospective studies are ongoing to determine the curability and long term toxicities of this preparative regimen. Overall Survival and Disease-Free Survival Sample Size: 42 patients Treated with RIT in 98153 Run Date: August 15, 2007 Overall Survival and Disease-Free Survival Sample Size: 42 patients Treated with RIT in 98153 Run Date: August 15, 2007

Adjuvant chemotherapy for patients with high-grade soft-tissue sarcomas of the extremity.

1988 ◽  
Vol 6 (9) ◽  
pp. 1491-1500 ◽  
Author(s):  
A E Chang ◽  
T Kinsella ◽  
E Glatstein ◽  
A R Baker ◽  
W F Sindelar ◽  
...  
Keyword(s):  
Overall Survival ◽  
Adjuvant Chemotherapy ◽  
Dose Regimen ◽  
Soft Tissue Sarcomas ◽  
Disease Free Survival ◽  
High Dose ◽  
Free Survival ◽  
High Dose Regimen ◽  
Disease Free

We have previously reported the results of a randomized trial that demonstrated the survival benefit of adjuvant chemotherapy in the treatment of patients with high-grade extremity sarcomas compared with no chemotherapy. This regimen included doxorubicin, cyclophosphamide, and methotrexate. This report updates and extends our experience. The median follow-up of this trial is now 7.1 years and reveals a 5-year disease-free survival of 75% and 54% for chemotherapy and no chemotherapy groups, respectively (two-sided P [P2] = .037). The 5-year overall survival for patients in this trial was 83% and 60% for the chemotherapy and no chemotherapy groups, respectively, with a trend towards improved survival in the chemotherapy arm (P2 = .124). Because of doxorubicin-induced cardiomyopathy we performed a subsequent randomized trial comparing this high-dose regimen to reduced cumulative doses of doxorubicin and cyclophosphamide without methotrexate. Eighty-eight patients were entered into this trial which has a median follow-up of 4.4 years. The 5-year disease-free and overall survival for patients treated with the reduced doses of chemotherapy was 72% and 75%, respectively, and was not significantly different from the high-dose regimen. No patients developed congestive heart failure on this study. We conclude that adjuvant chemotherapy improves disease-free survival in patients with extremity soft-tissue sarcomas. The overall survival advantage in patients receiving adjuvant chemotherapy in our initial randomized high-dose chemotherapy trial has diminished though it continues to favor the chemotherapy group. A reduced-dose chemotherapy regimen was found to be comparable to the high-dose regimen.

5-Year Results of Dose-Intensive Sequential Adjuvant Chemotherapy for Women With High-Risk Node-Positive Breast Cancer: A Phase II Study

1999 ◽  
Vol 17 (4) ◽  
pp. 1118-1118 ◽  
Author(s):  
C. Hudis ◽  
M. Fornier ◽  
L. Riccio ◽  
D. Lebwohl ◽  
J. Crown ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Overall Survival ◽  
Pilot Study ◽  
Adjuvant Chemotherapy ◽  
Disease Free Survival ◽  
Free Survival ◽  
Dose Dense ◽  
Disease Free

PURPOSE: We conducted a phase II pilot study of dose-intensive adjuvant chemotherapy with doxorubicin followed sequentially by high-dose cyclophosphamide to determine the safety and feasibility of this dose-dense treatment and to estimate the disease-free and overall survival in breast cancer patients with four or more involved axillary lymph nodes. PATIENTS AND METHODS: Seventy-three patients received adjuvant treatment with four cycles of doxorubicin 75 mg/m2 as an intravenous bolus every 21 days, followed by three cycles of cyclophosphamide 3,000 mg/m2 every 14 days with granulocyte colony-stimulating factor support. RESULTS: Seventy-one patients were assessable, and all but two completed all planned chemotherapy. There was no treatment-related mortality. The most common toxicity was neutropenic fever, which occurred in 39% of patients. Median disease-free survival is 66 months (95% confidence interval, 34 to 98 months), and median overall survival has not yet been reached. At 5 years of follow-up, the disease-free survival is 51.7%, and overall survival is 60.0%. There is no long-term treatment-related toxicity, and no cases of acute myelogenous leukemia or myelodysplastic syndrome have been observed. CONCLUSION: Our pilot study of doxorubicin followed by cyclophosphamide demonstrates the safety and feasibility of the sequential dose-dense plan. Long-term follow-up, although noncomparative, is promising. However, this regimen is associated with a higher incidence of toxicity (and also higher costs) than the standard dose and schedule of doxorubicin and cyclophosphamide, and therefore it should not be used as conventional therapy in the absence of demonstrated improvement of outcome. Randomized trials testing the dose-dense approach have been completed but not yet reported. Because the sequential plan can decrease overlapping toxicities, it is an appropriate platform for the addition of newer active agents, such as taxanes or monoclonal antibodies.

Age and Response after Autologous Stem Cell Transplantation (ASCT) Define a Group of Long-Term Event-Free Survivors among Patients (Pts) with Low-Grade Follicular Lymphoma (FL): A Single Institution Experience.

Blood ◽  
2004 ◽  
Vol 104 (11) ◽  
pp. 1883-1883
Author(s):  
Charalambos Andreadis ◽  
Elise A. Chong ◽  
Edward A. Stadtmauer ◽  
Selina M. Luger ◽  
David L. Porter ◽  
...  
Keyword(s):  
Multivariable Analysis ◽  
Disease Free Survival ◽  
Autologous Bone Marrow ◽  
Large Cell ◽  
High Dose ◽  
Low Grade ◽  
Free Survival ◽  
Disease Free

Abstract Introduction: FL is generally responsive to conventional-dose chemotherapy but long term disease-free survival (DFS) is uncommon. High-dose chemo-radiotherapy followed by ASCT has the potential to induce remission in this disease but the long-term benefit of this modality remains to be determined. Methods: Between 1990 and 2003, we transplanted 52 pts originally diagnosed with low-grade FL (31 grade 1, 21 grade 2). Twenty-five (48%) had biopsy-proven large cell transformation (FL grade 3 or diffuse large cell lymphoma) before ASCT. The median number of prior therapies was 2 (range: 1 to 7). Prior to ASCT, 45 pts (87%) were responsive to salvage therapy with 20 pts (38%) in CR. Five pts (10%) had chemo-resistant disease at the time of ASCT. High-dose regimens included BCNU-cyclophosphamide-etoposide (31%), melphalan/TBI (27%), and cyclophosphamide/TBI (25%). Thirty-eight pts (73%) received peripheral stem cells (PSCT) and 14 pts (27%) received autologous bone marrow (BM) with 4-hydroxyperoxycyclophosphamide (4-hc) purging in 9 cases (17%). The median age was 49 yrs (range: 29–65). Results: There was 1 treatment-related death during the first 100 days. After ASCT, 36 pts (69%) achieved a CR, 2 (4%) had a PR, and 7 (13%) had stable disease. Among those in CR, 20 (56%) had a CR pre-ASCT, 14 (41%) had a lesser response, and 1 (3%) was chemo-resistant. Median follow-up (f/u) of survivors was 5.3 yrs (range: 1.7 months to 12.4 yrs). The median overall survival (OS) has not yet been reached. The median event-free survival (EFS) is 3.4 yrs (range: 1.7 months to 12.4 yrs). Among complete responders, more than 50% are disease free at last follow-up (range 1.7 months to 12.1 yrs). Variables favorably affecting EFS and OS are age < 60 yrs (p = 0.007, 0.015 respectively), achievement of a CR after ASCT (p = 0.002, 0.001), absence of transformation (p = 0.038, 0.017), BM vs. PSCT (p = 0.042, 0.086), and 4-hc BM purging (p = 0.044, 0.059). Number of prior regimens, response prior to ASCT, type of preparative regimen, and addition of TBI, were not significantly associated with EFS, DFS, or OS. In multivariable analysis, achievement of CR after ASCT and age < 60 yrs are the only significant predictors of EFS and OS. Adjusted for age, 53% of pts with a CR after ASCT are alive and event-free at last f/u (range: 2.4 months to 12.4 yrs) (Figure 1). In contrast, the median EFS among pts without a CR is 0.5 yrs (range: 1.7 months to 5.3 yrs). Conclusion: ASCT is a reasonable therapeutic approach to FL, resulting in long term EFS for some pts, even with relapsed, refractory and/or transformed disease. In our experience, significant predictors of EFS and OS after ASCT are complete response and age <60. The appropriate application and timing of ASCT in the management of pts with FL needs to be further evaluated in randomized, controlled clinical trials. Figure Figure

Comparison of long-term outcome between endoscopic submucosal dissection and surgical resection for early gastric cancer.

2015 ◽  
Vol 33 (3_suppl) ◽  
pp. 144-144
Author(s):  
Boo Gyeong Kim ◽  
Byung-Wook Kim ◽  
Joon Sung Kim ◽  
Sung Min Park ◽  
Keun Joon Lim ◽  
...  
Keyword(s):  
Overall Survival ◽  
Survival Rate ◽  
Surgical Resection ◽  
Disease Free Survival ◽  
Overall Survival Rate ◽  
Free Survival ◽  
Resection Group ◽  
Disease Free

144 Background: The aim of this study is to evaluate the long-term clinical and oncologic outcome of ESD for differentiated EGC of an expanded indication compared to surgical resection. Methods: Retrospective analyses were performed in patients who underwent ESD or surgical resection for EGC of an expanded indication from 2006 and 2008 in Incheon St. Mary’s Hospital, Seoul St. Mary’s Hospital, Yeouido St. Mary’s Hospital, and St. Paul’s Hospital. First arm study was performed according to pre-ESD diagnosis including pathologic diagnosis and endoscopic findings. Second arm study was obtained from post-ESD final pathologic result. All the patients were checked with endoscopy and stomach CT regularly at least 5 years. Clinical outcomes, disease free survival and overall survival were compared between the ESD group and surgical resection group in each arm. Results: In first arm study, 41 patients who received ESD and 106 patients who received surgical resection were enrolled. Metachronous recur was found in 4 patients among ESD group and in 2 patients among surgical resection group during the follow up period. There was no local recurrence in both groups. The disease free survival was not different between the two groups (ESD vs surgical resection; 87.8 vs 95.3%, p=0.291). The 5-year overall survival rate was 100% in both groups. In second arm study, 74 patients who received ESD and 165 patients who received surgical resection were enrolled. Metachronous recur was found in 5 patients among ESD group and in 2 patients among surgical resection group during the follow up period. Local recurrence did not occur in both groups. Surgical resection group was superior to ESD group in disease free survival (97.6% vs 87.6%, p=0.002). The 5-year overall survival rate was 100% in both groups. Conclusions: ESD for EGC might be acceptable considering the overall survival rates. However, intensive surveillance should be performed to find the metachronous recur after ESD.

90Y-Ibritumomab Tiuxetan (Zevalin®) in Combination with High-Dose Therapy (HDT) Followed by Autologous Stem Cell Transplant (ASCT) May Improve Survival in Patients with Poor-Risk Follicular Lymphoma (FL) and Diffuse Large B-Cell Lymphoma (DLBCL): Results of a Retrospective Comparative Analysis.

Blood ◽  
2006 ◽  
Vol 108 (11) ◽  
pp. 327-327 ◽  
Author(s):  
Auayporn P. Nademanee ◽  
Amrita Krishnan ◽  
Nicole Tsai ◽  
Joycelynne Palmer ◽  
Arturo Molina ◽  
...  
Keyword(s):  
B Cell ◽  
Performance Status ◽  
Disease Free Survival ◽  
Disease Status ◽  
High Dose ◽  
Free Survival ◽  
Poor Risk ◽  
Disease Free

Abstract Since NHL is radiosensitive, total body irradiation (TBI) has been used as part of HDT and ASCT for NHL. However, due to short-term and long-term toxicity associated with TBI, alternative regimens have been developed. We have reported that Zevalin at conventional and high doses can be given in combination with HDT and ASCT in patients (pts) with poor-risk or relapsed B-cell NHL without additional toxicity. Given the efficacy of Zevalin in FL and DLBCL, we retrospectively evaluated the outcome of HDT and ASCT in pts with FL and DLBCL who received Zevalin-based HDT regimens (Z-ASCT) and compared to those receiving TBI-based regimen (TBI-ASCT)Between 1/2000 to 1/2006, 187 pts with FL grade I/II (30), FL grade III (20) and DLBCL (137) underwent HDT and ASCT, 62 received Z-ASCT while 125 received TBI-ASCT. For Z-ASCT, pts < 60 years old without prior radiotherapy (RT) received high-dose Zevalin in combination with high-dose etoposide and cyclophosphamide while pt > 60 yrs or with prior RT received conventional dose Zevalin plus high-dose BEAM. TBI-ASCT was performed during the same period for the following reasons: ineligible for Z-ASCT, pt refusal, physician preference and protocol closure. The pt characteristics between the two groups were similar with respect to histology, disease status, prior regimens, bulky disease, B symptoms and performance status. However, the median age was younger for TBI-ASCT (49 vs. 53, p=0.01) and there were more chemo-resistant pts in the Z-ASCT group (p=0.01). Results: At a median follow-up of 28 months (range 2–64) for Z-ASCT and 38 months (range 1–78) for TBI-ASCT, the 2-year overall survival (OS) and disease-free survival (DFS) were 91% (95% CI, 82–96) and 74% (95% CI, 64–82), respectively for Z-ASCT, and 76% (95% CI, 69–80) and 72% (95% CI, 65–77), respectively for TBI-ASCT(Figure 1). OS remained significantly different when first complete remission pts were excluded from analysis (p=0.019). Multivariate models were generated for the primary endpoints of the study (OS and DFS). The results of these analyses showed that the risk of death and/or relapse was less among the Z-ASCT pts after adjusting for baseline differences (ie. Age, performance status and chemosensitivity status at transplant), and other factors (i.e., disease status at transplant, number of previous chemotherapies) previously shown to be associated with survival/disease free survival post transplant (OS: p<0.01 | DFS: p<0.10). Conclusion: Zevalin in combination with HDT followed by ASCT was associated with significantly improved survival in pts with poor-risk or relapsed/refractory FL and DLCBL when compared to TBI-ASCT. Further studies and longer follow-up are required to evaluate the long-term efficacy and safety of Zevalin in the HDT/ASCT setting. Figure Figure

scholarly journals Robot-assisted minimally invasive thoracolaparoscopic esophagectomy versus open esophagectomy: long-term follow-up of a randomized clinical trial

2020 ◽  
Vol 33 (Supplement_2) ◽  
Author(s):  
Eline M de Groot ◽  
Sylvia van der Horst ◽  
B Feike Kingma ◽  
Lucas Goense ◽  
Pieter C van der Sluis ◽  
...  
Keyword(s):  
Overall Survival ◽  
Disease Free Survival ◽  
Rank Test ◽  
Robot Assisted ◽  
Short Term ◽  
Free Survival ◽  
Log Rank Test ◽  
Disease Free

ABSTRACT Initial results of the ROBOT, which randomized between robot-assisted minimally invasive esophagectomy (RAMIE) and open transthoracic esophagectomy (OTE), showed significantly better short-term postoperative outcomes in favor of RAMIE. However, it is not yet clarified if RAMIE is equivalent to OTE regarding long-term outcomes. The aim of this study was to report the long-term oncological results of the ROBOT trial in terms of survival and disease-free survival. This study is a follow-up study of the ROBOT trial, which was a randomized controlled trial comparing RAMIE to OTE in 112 patients with intrathoracic esophageal cancer. Both the trial protocol and short-term results were previously published. The primary outcome of the current study was 5-year overall survival. Secondary outcomes were disease-free survival and recurrence patterns. Analysis was by intention to treat. During the recruitment period, 109 patients were included in the survival analysis (RAMIE n = 54, OTE n = 55). Majority of patients had clinical stage III or IV (RAMIE 63%, OTE 55%) and received neoadjuvant chemoradiotherapy (80%). Median follow-up was 60 months (range 31–60). The combined 5-year overall survival rates for RAMIE and OTE were 41% (95% CI 27–55) and 40% (95% CI 26–53), respectively (log rank test P = 0.827). The 5-year disease-free survival rate was 42% (95% CI 28–55) in the RAMIE group and 43% (95% CI 29–57) in the OTE group (log rank test P = 0.749). Out of 104 patients, 57 (55%) developed recurrent disease detected at a median of 10 months (range 0–56) after surgery. No statistically difference in recurrence rate nor recurrence pattern was observed between both groups. Overall survival and disease-free survival of RAMIE are comparable to OTE. These results continue to support the use of robotic surgery for esophageal cancer.

scholarly journals Combination of CD19 and CD70 Specific Chimeric Antigen Receptor T Cells Achieves Long-Term Disease-Free Survival in Relapsed and Refractory Primary Central Nervous System Diffuse Large B Cell Lymphoma

Blood ◽  
2018 ◽  
Vol 132 (Supplement 1) ◽  
pp. 5389-5389 ◽  
Author(s):  
Sanfang Tu ◽  
Rui Huang ◽  
Xuan Zhou ◽  
Yanjie He ◽  
Zhao Liang ◽  
...  
Keyword(s):  
T Cells ◽  
Disease Free Survival ◽  
B Cell Lymphoma ◽  
High Dose ◽  
Free Survival ◽  
Large B Cell Lymphoma ◽  
Car T ◽  
Disease Free

Abstract Background: Chimeric antigen receptor-modified T cells (CARTs) targeting CD19 has illustrated therapeutic efficacy in diffuse large B cell lymphoma (DLBCL). However, severe cytokine release syndrome (sCRS) reaction and CAR-T-cell-related encephalopathy syndrome (CRES) are the main adverse reactions of CART therapy. Because of the concern of severe CRES which is associated with potential mortality, patients with primary central nervous system Lymphoma(PCNSL) are excluded in most of CART clinical trials. CD70 is a promising therapeutic target due to the restricted expression pattern in normal tissues and overexpression in some lymphoma tissues, so CD70 specific CARTs maybe avoid CD19-negative relapse .Here we report a case with refractory and relapsed PCNSL who achieved long-term disease-free survival by combination therapy of CD19 and CD70 specific CARTs without inducing CRS or CRES. Methods: CD3+ cells were selected from the apheresis PBMC and activated before lentiviral 4SCAR infection. The cells were transduced with a caspase 9-inducible, safety-engineered lentivector CAR containing anti-CD19 or -CD70 scFv fused with multiple intracellular signaling domains: CD28/CD27/CD3z-iCasp9 (4SCAR19 or 4SCAR70). The quality of apheresis cells, gene transfer and T cell proliferation efficiencies, and effective CAR T infusion dose were quantitatively scored and documented. Tumor sections were immunohistochemically stained with different antibodies including anti-CD19 and anti-CD70 antibodies to confirm antigen expression. The patient received cyclophosphamide and fludarabine conditioning regimen before the dual CARTs cell infusions. Case presentation: A 67-year-old male who was diagnosed as PCNSL of DLBCL in 2011.The patient received 6 cycles of temozolomide and high does methotrexate, and achieved CR. In December 2016 he relapsed and was treated with right frontal lobe space-occupying resection and multi-course chemotherapy including 2 course of rituximab, high dose methotrexate and temozolomide ,and 6 courses of rituximab, high dose methotrexate and ibrutinib,and he achieved remission again.However, He relapsed again in August 2017, with the clinical symptoms of dizziness , fatigue, left corners of the mouth askew and occlusal difficulties.MRI presented a residual mass on the right side of the postoperative cavity of 26mm*35mm*30mm and stale hemorrhage in left basal ganglia. After confirmation for CD19 and CD70 expression in his tumor specimens, the pt enrolled in the clinicaltrail :"Combination CART cell therapy targeting hematological malignancies"(clinicaltrail.gov registry NCT03125577).He received 4SCAR19 and 4SCAR70 T cells targeting CD19 and CD70 following lymphodepletion chemotherapy with FC regimen conditioning (FLU 30mg/m2, d1-3; CTX 300mg/m2, d1-3) in October 2017. Brain MRI 1 month later showed complete remission and the pt had symptomatic improvement. To date, after more than 8 months of follow-up, the pt remains in CR (figure1) and CART cells still can be detected . There was no CRS or CRES during the treatment and in follow-up period. Conclusions: The study results demonstrate that CARTs are able to pass through the blood-brain barrier without inducing CRS or CRES, suggesting that CNS tumor is not an absolute contraindication to 4sCART therapy. In addition, the combination of CD19 and CD70 specific 4sCARTs could effectively target PCNSL and achieves long-term disease-free survival without sCRS or CRES. Disclosures No relevant conflicts of interest to declare.

Long-Term Results of the International Adjuvant Lung Cancer Trial Evaluating Adjuvant Cisplatin-Based Chemotherapy in Resected Lung Cancer

2010 ◽  
Vol 28 (1) ◽  
pp. 35-42 ◽  
Author(s):  
Rodrigo Arriagada ◽  
Ariane Dunant ◽  
Jean-Pierre Pignon ◽  
Bengt Bergman ◽  
Mariusz Chabowski ◽  
...  
Keyword(s):  
Lung Cancer ◽  
Overall Survival ◽  
Adjuvant Chemotherapy ◽  
Disease Free Survival ◽  
Long Term Results ◽  
Cancer Trial ◽  
Free Survival ◽  
Disease Free

Purpose Based on 5-year or shorter-term follow-up data in recent randomized trials, adjuvant cisplatin-based chemotherapy is now generally recommended after complete surgical resection for patients with non–small-cell lung cancer (NSCLC). We evaluated the results of the International Adjuvant Lung Cancer Trial study with three additional years of follow-up. Patients and Methods Patients with completely resected NSCLC were randomly assigned to three or four cycles of cisplatin-based chemotherapy or to observation. Cox models were used to evaluate treatment effect according to follow-up duration. Results The trial included 1,867 patients with a median follow-up of 7.5 years. Results showed a beneficial effect of adjuvant chemotherapy on overall survival (hazard ratio [HR], 0.91; 95% CI, 0.81 to 1.02; P = .10) and on disease-free survival (HR, 0.88; 95% CI, 0.78 to 0.98; P = .02). However, there was a significant difference between the results of overall survival before and after 5 years of follow-up (HR, 0.86; 95% CI, 0.76 to 0.97; P = .01 v HR, 1.45; 95% CI, 1.02 to 2.07; P = .04) with P = .006 for interaction. Similar results were observed for disease-free survival. The analysis of non-lung cancer deaths for the whole period showed an HR of 1.34 (95% CI, 0.99 to 1.81; P = .06). Conclusion These results confirm the significant efficacy of adjuvant chemotherapy at 5 years. The difference in results beyond 5 years of follow-up underscores the need for the long-term follow-up of other adjuvant lung cancer trials and for a better identification of patients deriving long-term benefit from adjuvant chemotherapy.

scholarly journals O20: PREOPERATIVE INTRAVENOUS IRON THERAPY AND SURVIVAL AFTER COLORECTAL CANCER SURGERY: LONG TERM RESULTS FROM THE INTRAVENOUS IRON IN COLORECTAL CANCER-ASSOCIATED ANAEMIA (IVICA) TRIAL

2021 ◽  
Vol 108 (Supplement_1) ◽  
Author(s):  
EA Dickson ◽  
BD Keeler ◽  
O Ng ◽  
A Kumar ◽  
MJ Brookes ◽  
...  
Keyword(s):  
Colorectal Cancer ◽  
Overall Survival ◽  
Disease Free Survival ◽  
Intravenous Iron ◽  
Cancer Surgery ◽  
Colorectal Cancer Surgery ◽  
Free Survival ◽  
Disease Free

Abstract Background Intravenous iron is now the standard treatment to correct preoperative anaemia. However, iron may promote tumour growth and progression which could influence cancer recurrence and survival. We explore the long term postoperative outcomes of patients receiving oral (OI) or intravenous iron (IVI) as part of a randomised controlled trial. Method The multicentre IVICA trial randomised anaemic colorectal cancer patients in a 1:1 fashion to receive either OI or IVI prior to their elective operation. Follow up analysis of all patients was performed and Kaplan-Meier survival estimates and Cox proportional hazard models were used to compare groups. A pooled analysis comparing patients who did/did not achieve preoperative resolution of anaemia was also undertaken. Result, Data were available for 106 of the 116 IVICA patients (OI n=55, IVI n=51). Median follow up was 61 months (IQR 38-68, [range 1-80]). Overall survival estimates at 3 and 5 years were 82%(95% CI 76-90) and 72%(58-83) respectively for OI and 75%(61-86) and 59%(45-72) for IVI, P=0.106. No significant difference in 5-year overall survival (HR 1.73, 95% CI 0.90-3.34 P=0.102) or disease-free survival (HR 1.50, 95% CI 0.83-2.73 P=0.182) was observed between groups. Those non-anaemic at operation demonstrated improved 5 year overall survival (HR 3.26 [1.01-10.58], P=0.05). Non-significant trends in improved disease-free survival (HR 2.29 [0.91-5.81], p=0.08) were observed for the non-anaemic group Conclusion Preoperative correction of anaemia confers a postoperative survival advantage following elective colorectal cancer surgery. Due to its superior efficacy intravenous iron is recommended as the treatment of choice for this anaemia. Take-home message Preoperative correction of anaemia, achieved most effectively with intravenous iron, may offer improved long term postoperative survival after colorectal cancer surgery.

scholarly journals Two or More Chemotherapy Consolidation Courses, Followed By Autologous Bone Marrow Transplantation, and MRD Negativity, Give Long Term Overall Survival in Acute Myeloid Leukemia Patients

Blood ◽  
2015 ◽  
Vol 126 (23) ◽  
pp. 3198-3198
Author(s):  
Giovanni Marconi ◽  
Cristina Papayannidis ◽  
Federico Mosna ◽  
Michele Gottardi ◽  
Giorgia Simonetti ◽  
...  
Keyword(s):  
Overall Survival ◽  
Myeloid Leukemia ◽  
Autologous Bone Marrow Transplantation ◽  
Disease Free Survival ◽  
Normal Karyotype ◽  
Autologous Bone Marrow ◽  
Free Survival ◽  
Disease Free

Abstract Introduction. Autologous Bone Marrow Transplantation (Auto-BMT) is currently rarely used in the treatment of Acute Myeloid Leukemia (AML). However, it may represent a good therapeutic option in a specific subset of patients, mainly in consolidation of both low risk (LR) and MRD negative AML without an available HLA matched donor. Aims. To review our database of AML patients who received Auto-BMT from 2005 to 2014 and who were referred to Bologna Institution, in order to assess the efficacy of the procedure in terms of Overall Survival (OS) and Disease Free Survival (DFS). Patients and methods: From 2005 to 2014, 98 AML patients underwent Auto-BMT in several Italian Institutions. 89/98 patients are evaluable for survival and outcome data. The 89 patients considered (42 female, 47 male), had a median age of 49 years (range 15-70). Cytogenetics was performed in all patients by conventional karyotype (22 patients were also analyzed by Single Nucleotide Polymorphisms Array); molecular analysis (FLT3 TKD and ITD, and NPM1 mutational analysis) was available for 51/89 patients. Molecular monitoring by specific fusion transcripts (CBF-MYH11 and AML1-ETO) was performed in CBF positive leukemias (inv(16) and t(8;21)) at the time of diagnosis, after induction, consolidation courses, and every 3 months in the first 2 years of follow-up. Based on this data, and according to ELN guidelines, a risk stratification identified 41 patients with a LR AML (t(8:21), inv(16) or NPM1+/FLT3- with normal karyotype), 4 patients with a high risk (HR) AML (complex karyotype or FLT3 ITD mutated or inv(3) or t(6;9)) and 44 patients with a standard risk (SR) AML (normal karyotype, other alterations). Results. All the patients received an induction chemotherapy treatment, as follows: a "3+7-like" course in 48 cases, a Fludarabine-based regimen in 20 patients and a Gemtuzumab-ozogamicin (GO)-based regimen in 21. 83/89 (93.3%) patients received a median of 2 consolidation courses of chemotherapy (range 1-4) before proceeding to Auto-BMT, performed in 1st CR. 6/89 (6.7%) patients received Auto-BMT in first relapse. 41 patients relapsed after auto-BMT and were treated with a re-induction chemotherapy, or were enrolled in clinical trials. 24 patients reached a 2nd complete remission, and 12 patients underwent an allogeneic BMT in 2nd CR. With a median follow up of 6 years, the median Overall Survival (OS) of the entire population was 64.3 months (range 5.8-294.2 months); the 1 year OS and the 5 years OS were, 97.1%, and 67.9%, respectively. The median Disease Free Survival (DFS) of the 83 patients treated with Auto-BMT in 1st CR was 36 months (range 1.3-293 months). The 1-year DFS and the 5-years DFS were 85% and 56.7%, respectively. Transplant related mortality (TRM, death in 100 days after BMT) was 1.2% for auto-BMT and 6.5% for allogeneic BMT. First, to assess the role of the number of consolidation courses we compared patients who received none or 1 consolidation course with patients who received 2 or more cycles, who showed a better OS (p= 0.0061, Figure 1). There was no statistical difference in terms of OS between young and elderly patients (cut off=65 years). Second, we compared patients who achieved a negative minimal residual disease status before auto-BMT (n=37) with patients who did not (n=9). MRD negativity offered a significantly better outcome in terms of 5-years OS (83.4% and 50% respectively); the median OS of MRD neg was not yet reached; the median OS of MRD pos was 27 months (p= 0.0130) (Figure 2). Conclusions: Auto-BMT offers a chance to achieve long-term DFS and OS if used as a consolidation therapy both in patients with LR and SR AML. The major role could be played in MRD negative patients, offering the best chances to achieve a long-term OS. Auto-BMT can be also a good choice as consolidation therapy for elderly patients, in which allo-BMT could induce high morbidity and mortality rates. The small patients cohort and the retrospective analysis don't allow us to define the best induction therapy to be used before auto-BMT. However, based on our findings we suggest a therapy schedule including two or more consolidation courses in patients who obtain a first CR, and to proceed then to auto-BMT. Acknowledgments: work supported by ELN, AIL, AIRC, Progetto Regione-Università 2010-12 (L.Bolondi), Fondazione del Monte di Bologna e Ravenna, FP7 NGS-PTL project. Figure 1. Figure 1. Figure 2. Figure 2. Disclosures Soverini: Novartis, Briston-Myers Squibb, ARIAD: Consultancy. Rodeghiero:Celgene Corporation: Honoraria, Research Funding. Cavo:Janssen-Cilag, Celgene, Amgen, BMS: Honoraria. Martinelli:AMGEN: Consultancy; Novartis: Consultancy, Speakers Bureau; Ariad: Consultancy; BMS: Consultancy, Speakers Bureau; ROCHE: Consultancy; Pfizer: Consultancy; MSD: Consultancy.

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