Gemtuzumab Ozogamicin Versus Best Supportive Care in Older Patients With Newly Diagnosed Acute Myeloid Leukemia Unsuitable for Intensive Chemotherapy: Results of the Randomized Phase III EORTC-GIMEMA AML-19 Trial.

@article{Amadori2016GemtuzumabOV,
  title={Gemtuzumab Ozogamicin Versus Best Supportive Care in Older Patients With Newly Diagnosed Acute Myeloid Leukemia Unsuitable for Intensive Chemotherapy: Results of the Randomized Phase III EORTC-GIMEMA AML-19 Trial.},
  author={Sergio Amadori and Stefan Suciu and Dominik Selleslag and Franco Aversa and Gianluca Gaidano and Maurizio Musso and Luciana Annino and Adriano Venditti and Maria Teresa Voso and Carla Mazzone and Domenico Magro and Paolo de Fabritiis and Petra Muus and Giuliana Alimena and Marco Mancini and Anne Hagemeijer and Francesca Paola Paoloni and Marco Vignetti and Paola Fazi and Liv Meert and Safaa Mahmoud Ramadan and Roelof Willemze and Theo de Witte and Fr{\'e}d{\'e}ric Baron},
  journal={Journal of clinical oncology : official journal of the American Society of Clinical Oncology},
  year={2016},
  volume={34 9},
  pages={
          972-9
        }
}
  • S. Amadori, S. Suciu, +21 authors F. Baron
  • Published 2016
  • Medicine
  • Journal of clinical oncology : official journal of the American Society of Clinical Oncology
PURPOSE To compare single-agent gemtuzumab ozogamicin (GO) with best supportive care (BSC) including hydroxyurea as first-line therapy in older patients with acute myeloid leukemia unsuitable for intensive chemotherapy. [...] Key Method Patients who did not progress after GO induction could receive up to eight monthly infusions of the immunoconjugate at 2 mg/m(2). Randomization was stratified by age, WHO performance score, CD33 expression status, and center.Expand
Gemtuzumab Ozogamicin in NPM1-Mutated Acute Myeloid Leukemia: Early Results From the Prospective Randomized AMLSG 09-09 Phase III Study
  • R. Schlenk, P. Paschka, +30 authors H. Döhner
  • Medicine
  • Journal of clinical oncology : official journal of the American Society of Clinical Oncology
  • 2019
TLDR
A randomized trial to evaluate gemtuzumab ozogamicin in combination with intensive induction and consolidation therapy in NPM1-mutated AML did not meet its early primary end point of EFS, mainly as a result of a higher early death rate in the GO arm. Expand
Venetoclax Combined With Low-Dose Cytarabine for Previously Untreated Patients With Acute Myeloid Leukemia: Results From a Phase Ib/II Study
  • A. Wei, S. Strickland, +17 authors G. Roboz
  • Medicine
  • Journal of clinical oncology : official journal of the American Society of Clinical Oncology
  • 2019
TLDR
Venetoclax plus LDAC has a manageable safety profile, producing rapid and durable remissions in older adults with AML ineligible for intensive chemotherapy, and high remission rate and low early mortality combined with rapid and Durable remission make venetoclAX and LDAC an attractive and novel treatment for older adults not suitable forintensive chemotherapy. Expand
Fractionated gemtuzumab ozogamicin combined with intermediate-dose cytarabine and daunorubicin as salvage therapy in very high-risk AML patients: a bridge to reduced intensity conditioning transplant?
TLDR
It is suggested that salvage therapy with fractionated GO combined with intermediate-dose cytarabine and daunorubicin in very high-risk patients may serve as a potential bridge therapy to RIC transplant. Expand
Venetoclax plus LDAC for patients with untreated AML ineligible for intensive chemotherapy: phase 3 randomized placebo-controlled trial.
BACKGROUND Effective treatment options are limited for patients with acute myeloid leukemia (AML) who cannot tolerate intensive chemotherapy. METHODS Adults ≥18 years with newly diagnosed AMLExpand
Safety of gemtuzumab ozogamicin as monotherapy or combination therapy in an expanded-access protocol for patients with relapsed or refractory acute myeloid leukemia
TLDR
Gemtuzumab ozogamicin was generally well tolerated in patients with R/R AML or APL and most frequent treatment-related grade ≥3 AEs were hematologic AEs. Expand
Measurable residual disease in elderly acute myeloid leukemia: results from the PETHEMA-FLUGAZA phase 3 clinical trial.
TLDR
This study supports MRD assessment to refine CR after semi-intensive therapy or hypomethylating agents, but unveils that improved sensitivity is warranted to individualize treatment and prolong survival of elderly AML patients achieving undetectable MRD. Expand
Not type of induction therapy but consolidation with allogeneic hematopoietic cell transplantation determines outcome in older AML patients: A single center experience of 355 consecutive patients.
Therapeutic decision making is often challenging in older AML patients. We collected retrospective data of 355 consecutive AML patients (≥60 years) who were treated with intensive chemotherapy (IC)Expand
Venetoclax with azacitidine or decitabine in patients with newly diagnosed acute myeloid leukemia: Long term follow‐up from a phase 1b study
This analysis represents the longest‐term follow‐up for patients with acute myeloid leukemia (AML) treated with 400 mg of venetoclax plus azacitidine or decitabine. Adults with newly diagnosed AMLExpand
Comparison of the modified low-dose cytarabine and etoposide with decitabine therapy for elderly acute myeloid leukemia patients unfit for intensive chemotherapy
TLDR
The results suggested that the outcomes of classical LDAC could be improved by modest modifications, to be comparable to those of DAC. Expand
Gemtuzumab ozogamicin monotherapy prior to stem cell infusion induces sustained remission in a relapsed acute myeloid leukemia patient after allogeneic stem cell transplantation
TLDR
A relapsed AML patient who was treated with GO monotherapy followed by stem cell infusion and Gemtuzumab Ozogamicin has been used as a part of RIC regimens to add anti-tumor efficacy. Expand
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References

SHOWING 1-10 OF 33 REFERENCES
Randomized trial of two schedules of low‐dose gemtuzumab ozogamicin as induction monotherapy for newly diagnosed acute myeloid leukaemia in older patients not considered candidates for intensive chemotherapy. A phase II study of the EORTC and GIMEMA leukaemia groups (AML‐19)
TLDR
The day 1 + 8 schedule, which was associated with the highest rate of DnP, met the statistical criteria to be selected as the preferred regimen for phase III comparison with best supportive care. Expand
Phase II pilot trial of gemtuzumab ozogamicin (GO) as first line therapy in acute myeloid leukemia patients age 65 or older.
TLDR
Early results suggest that the option of single agent monoclonal antibody therapy is viable in this patient population and that additional studies are warranted with this agent either alone or in combination as initial therapy. Expand
Identification of patients with acute myeloblastic leukemia who benefit from the addition of gemtuzumab ozogamicin: results of the MRC AML15 trial.
  • A. Burnett, R. Hills, +7 authors K. Wheatley
  • Medicine
  • Journal of clinical oncology : official journal of the American Society of Clinical Oncology
  • 2011
TLDR
A substantial proportion of younger patients with AML have improved survival with the addition of GO to induction chemotherapy with little additional toxicity. Expand
Multicenter, randomized, open-label, phase III trial of decitabine versus patient choice, with physician advice, of either supportive care or low-dose cytarabine for the treatment of older patients with newly diagnosed acute myeloid leukemia.
TLDR
In older patients with AML, decitabine improved response rates compared with standard therapies without major differences in safety, and an unplanned survival analysis showed a benefit for decit abine, which was not observed at the time of the primary analysis. Expand
Effect of gemtuzumab ozogamicin on survival of adult patients with de-novo acute myeloid leukaemia (ALFA-0701): a randomised, open-label, phase 3 study
TLDR
The use of fractionated lower doses of gemtuzumab ozogamicin allows the safe delivery of higher cumulative doses and substantially improves outcomes in patients with acute myeloid leukaemia. Expand
Azacitidine prolongs overall survival compared with conventional care regimens in elderly patients with low bone marrow blast count acute myeloid leukemia.
  • P. Fenaux, G. Mufti, +13 authors L. Silverman
  • Medicine
  • Journal of clinical oncology : official journal of the American Society of Clinical Oncology
  • 2010
TLDR
In older adult patients with low marrow blast count (20% to 30%) WHO-defined AML, azacitidine significantly prolongs OS and significantly improves several patient morbidity measures compared with CCR. Expand
The addition of gemtuzumab ozogamicin to low-dose Ara-C improves remission rate but does not significantly prolong survival in older patients with acute myeloid leukaemia: results from the LRF AML14 and NCRI AML16 pick-a-winner comparison
TLDR
This randomised trial compared the addition of the immunoconjugate, gemtuzumab ozogamicin (GO), at a dose of 5 mg on day 1 of each course of LDAC with the intention of improving the remission rate and consequently survival. Expand
A phase 2 trial of azacitidine and gemtuzumab ozogamicin therapy in older patients with acute myeloid leukemia.
This trial tested the safety and efficacy of a regimen consisting of hydroxyurea followed by azacitidine, 75 mg/m(2) for 7 days, and gemtuzumab ozogamicin, 3 mg/m(2) on day 8, in older patients withExpand
A phase 3 study of gemtuzumab ozogamicin during induction and postconsolidation therapy in younger patients with acute myeloid leukemia.
TLDR
In this study, the addition of GO to induction or postconsolidation therapy failed to show improvement in CR rate, disease-free survival, or overall survival. Expand
International phase 3 study of azacitidine vs conventional care regimens in older patients with newly diagnosed AML with >30% blasts.
TLDR
Univariate analysis showed favorable trends for azacitidine compared with CCR across all subgroups defined by baseline demographic and disease features, and adverse events were consistent with the well-established safety profile of azacItidine. Expand
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