Role Of Maintenance Therapy Research Articles

The Role of Maintenance Therapy in the Treatment of Newly Diagnosed Multiple Myeloma

The Role of Maintenance Therapy in the Treatment of Newly Diagnosed Multiple Myeloma

Consensus recommendations for systemic therapies in the management of relapsed Ewing sarcoma: A report from the National Ewing Sarcoma Tumor Board.

Ewing sarcoma (ES) is a malignant tumor of bone and soft tissue that most often occurs in children, adolescents, and young adults. Debate and controversy remain in the management of relapsed/refractory ES (RR-ES). The authors leveraged the expertise assembled by the National Ewing Sarcoma Tumor Board, a multidisciplinary virtual tumor board that meets monthly to discuss challenging cases of ES. In this review, they focus on select topics that apply to the management of patients with RR-ES. The specific topics covered include the initial approach of such patients and discussion of the goals of care, the role of molecular testing, chemotherapy regimens and novel agents to consider, the role of maintenance therapy, and the use of high-dose chemotherapy with autologous stem cell rescue. The data referenced are often limited to subgroup analyses and/or compiled from multiple sources. Although not intended to replace the clinical judgement of treating physicians, these guidelines are intended to support clinicians and provide some clarity and recommendations for the management of patients with RR-ES. PLAIN LANGUAGE SUMMARY: Ewing sarcoma (ES) is a bone and soft tissue cancer that most often occurs in teenagers and young adults. This article uses the experience of the National Ewing Sarcoma Tumor Board, a multi-institution, multidisciplinary virtual tumor board that meets monthly to discuss challenging cases of ES and to address questions related to the treatment of patients with relapsed ES. Although not intended to replace the clinical judgement of treating physicians and limited by available data, these consensus recommendations will support clinicians who treat patients with this challenging malignancy, made even more difficult when it recurs.

Efficacy and safety of rituximab induction therapy and effect of rituximab maintenance for IgG4-related disease: a systematic review and meta-analysis

BackgroundPrevious studies have reported that rituximab (RTX) therapy might be beneficial in reducing relapse rates in patients with IgG4-related disease (IgG4-RD). Therefore, we aimed to systematically assess the efficacy and safety of RTX induction treatment and the effect of RTX maintenance in patients with IgG4-RD. MethodsThe protocol was registered in the PROSPERO (CRD42023427352). PubMed, Embase, the Cochrane database, Scopus, and the Web of Science were interrogated to identify studies that evaluated the impact of RTX on prognosis in IgG4-RD. We explored the impact of various subgroups of factors on relapse outcomes and focused on the possible role of maintenance therapy in reducing relapse rates. The pooled incidence of adverse events of RTX therapy and the influencing factors have also been evaluated. ResultsEighteen studies comprising 374 patients (mean age 56.0 ± 8.7 years; male 73.7 %) with a mean follow-up duration of 23.4 ± 16.3 months were included. The pooled estimate of the response rate, complete remission rate, overall relapse rate, adverse event rate, and serious adverse event rate of RTX induction therapy were 97.3 % (95 % CI, 94.7 %–99.1 %), 55.8 % (95 % CI, 39.6 %–71.3 %), 16.9 % (95 % CI, 8.7 %–27.1 %), 31.6 % (95 % CI, 16.7 %–48.9 %) and 3.9 % (95 % CI, 0.8 %–8.9 %), respectively. In subgroup analysis, the pooled relapse rate was significantly lower in studies with maintenance than without maintenance (2.8% vs 21.5 %, p < 0.01). Pooled Kaplan-Meier relapse curves also demonstrated that RTX maintenance therapy provided a better prognosis. ConclusionsRTX induction therapy appears to have satisfactory efficacy in the induction of remission in IgG4-RD. In addition, prophylactic RTX maintenance therapy after induction may be beneficial in preventing relapse of IgG4-RD.

The role of maintenance therapy following autologous stem cell transplantation in newly diagnosed multiple myeloma: Considerations on behalf of the Chronic Malignancies Working Party of the EBMT.

Recent treatment advancements in multiple myeloma have led to significant improvements in patient outcomes. Maintenance therapy following autologous haematopoietic stem cell transplantation (AHCT) is now standard of care and has been demonstrated to prolong and deepen treatment responses. Currently, lenalidomide remains the single agent that has been approved for maintenance post-AHCT in Europe and the USA which, if tolerated, is continued until disease progression. The treatment landscape is rapidly expanding however, and the optimal personalised maintenance approach for a patient is becoming more complex. Treatment outcomes for patients with high-risk disease remain poor and choice of maintenance in this population also remains unclear. This review article evaluates up-to-date literature regarding established maintenance approaches. It further analyses ongoing studies exploring maintenance regimens using combination and novel agents, approaches to maintenance in patients with cytogenetic high-risk disease and minimal residual disease response-adapted strategies that reflect the current evolving treatment paradigm.

Autologous stem cell transplantation in adult patients with intermediate-risk acute myeloid leukemia in first complete remission and no detectable minimal residual disease. A comparative retrospective study with haploidentical transplants of the global committee and the ALWP of the EBMT

In patients with acute myeloid leukemia (AML) of intermediate-risk (IR) in first remission (CR1) with no measurable residual disease (MRD negative), the choice of the best consolidation is questionable. 1122 adult patients from 196 centers, transplanted in 2010-21 were analyzed: 547 received an autologous stem cell transplantation (ASCT) and 575 a Haploidentical donor transplant. Because of a significant interaction, comparisons were done separately for patients with wild-type FLT3 (FLT3-wt) and FLT3-ITD mutation (FLT3-ITD). In FLT3-wt patients, haploidentical transplants had two year lower relapse incidence (RI) (16.9% versus 32.6%; HR = 0.40, p < 0.001), higher NRM higher (17.2% vs 3.5%; HR = 7.02, p < 0.001), similar LFS (65.9% vs 63.8%; p = 0.37) and lower OS (73.2% vs 80.6%; HR = 1.69, p = 0.018). In FLT3-ITD patients, haploidentical transplants had two year lower RI (8.2% vs 47.8%; HR = 0.14, p < 0.001) higher NRM (20.2% vs 5.6%; HR = 3.43, p = 0.002), better LFS (71.5% vs 46.6%; HR = 0.53, p = 0.007) and similar OS (73.5% vs 61.9%; p = 0.44). In IR AML patients with FLT3-wt in MRD negative CR1, autologous stem cell transplantation is a valid option, while in patients with FLT3-ITD, haploidentical transplant is better. Whether autologous transplantation is superior to chemotherapy in FLT3-wt patients and the role of maintenance therapy with FLT3 inhibitors remain to be studied.

A retrospective study of autologous hematopoietic stem cell transplantation for peripheral T-cell lymphoma: pre-transplant patients with partial remission benefit from post-transplant maintenance therapy.

Whether autologous hematopoietic stem cell transplantation (ASCT) improves the survival of patients with peripheral T-cell lymphoma (PTCL) remains controversial. Some studies have demonstrated that the efficacy of ASCT is superior in patients with complete remission (CR), whereas patients with partial remission (PR) remain vulnerable to relapse after ASCT, resulting in decreased survival rates. Maintenance therapy after chemotherapy may reduce the relapse rate of PTCL and improve survival; however, the role of maintenance therapy after ASCT in PTCL remains unclear. In this study, we aimed to analyze the efficacy of ASCT and post-transplant maintenance therapy in PTCL. We retrospectively analyzed the clinical data of 69 patients with PTCL who underwent ASCT at our center between November 2001 and November 2021. According to the patients' intention, thirty patients received post-transplant maintenance treatment, whereas 39 did not. The overall survival (OS) and progression-free survival (PFS) between the groups were compared using the log-rank test. At a median follow-up of 36 months, the entire cohort's 3-year OS and PFS were 67.8% and 53.0%, respectively. The 3-year OS and PFS of patients with CR1, CR2, and PR were 85.3% and 65.4%, 80.0% and 60.0%, and 38.4% and 32.0%, respectively (OS: P=0.001; PFS: P=0.003). The relapse rates between the groups with or without maintenance therapy were 26.7% vs. 52.2%, the 3-year OS was 86.0% vs. 54.2% (P=0.004), and the 3-year PFS was 73.3% vs. 37.5% (P=0.004). Further analysis revealed that the efficacy of maintenance therapy was not significant in patients with CR1 and CR2, whereas patients with PR benefited from maintenance therapy. The relapse rate of patients with PR who received or did not receive maintenance therapy was 33.3% vs. 78.7%, 3-year OS was 66.7% vs. 21.9% (P=0.007), and 3-year PFS was 66.7% vs. 12.5% (P=0.004). Patients with CR in PTCL benefit from ASCT, and post-transplant maintenance therapy reduces the relapse rate and significantly improves OS and PFS in patients with PR.

Maintenance therapy after allogeneic hematopoietic stem cell transplantation for patients with multiple myeloma.

In the last two decades, proteasome inhibitors (PIs), immunomodulatory drugs (IMiDs), and monoclonal antibodies have greatly improved the overall survival of patients with multiple myeloma. However, multiple myeloma remains incurable, and high-risk patients have poor long-term survival. Although allogeneic hematopoietic stem cell transplantation (allo-HCT) is not considered standard therapy because of relatively high transplant-related mortality and relapse rates, the graft-versus-myeloma (GVM) effect makes it a potentially curative therapy. Therefore, allo-HCT remains a treatment option for younger patients and those with high-risk myeloma. Maintenance therapy with novel agents has recently been attempted to reduce relapse in patients undergoing allo-HCT, but its effectiveness remains unclear. This review focuses on the role of maintenance therapy after allo-HCT in patients with myeloma. Maintenance therapy using IMiDs and/or PIs after allo-HCT may be effective in reducing relapse or improving response because it may prevent early progression before achievement of the GVM effect or enhance the GVM effect. However, care must be taken to avoid complications, such as graft-versus-host disease. Further studies are necessary to determine the optimal maintenance drugs, drug combinations, dosing, start timing, and number of cycles.

Efficacy and Satisfaction of Low Doses UVA1 Phototherapy: A Spanish Experience from a Single Centre.

UVA1 phototherapy is a treatment used for multiple dermatological conditions. The optimal therapeutic regimens and dosing of UVA1 are a matter of debate. The dosages used vary widely between published studies and there are no evidence-based protocols that provide data on dosage, duration, or the role of maintenance therapy. The purpose of this study is to evaluate the experience in our medical center regarding treatment with UVA1, as well as the degree of patient satisfaction with the treatment according to their pathology. We present a retrospective evaluation of outcomes, treatment tolerability, and satisfaction in adult patients using a low dose of UVA1 phototherapy, administered in our dermatologic service between 2019 and 2022. A total of 78 patients were treated with UVA1, of whom 46 patients (59%) were over 18 years old, completed treatment, and gave their consent. The overall objective clinical response rate was 91.30% (42/46), achieving a complete response in 17 (36.96%) patients, partial response in 25 (54.34%), and no response in 4 (8.70%). The complete response rates recorded were high in morphea, scleredema, or chronic hand eczema. In terms of the level of satisfaction objectively measured by TSQM-9 version 1.4, highlighting high scores obtained in mastocytosis, systemic sclerosis, morphea, scleredema, chronic hand eczema, or prurigo nodularis (over 65 points). We present a review of treatment with UVA1 phototherapy at low doses with good response in a wide variety of dermatological pathologies.

SOHO State of the Art Updates and Next Questions |The Role of Maintenance Therapy in Acute Myeloid Leukemia.

Acute myeloid leukemia (AML) is an aggressive disease predominantly affecting the elderly population. Although, up to 65% of patients with AML achieve a complete remission with standard induction chemotherapy, the majority of patients will relapse and succumb to the disease. Although maintenance therapy is a component of standard management for various hematological malignancies, such as acute lymphoblastic leukemia (ALL), acute promyelocytic leukemia (APL) or multiple myeloma, past studies investigating the role of maintenance therapy in AML were unable to demonstrate an advantage in overall survival, and therefore, it has not been an established practice in the treatment of AML. For patients, who are not candidates for stem cell transplant, effective AML maintenance therapies are needed in order to reduce the risk of relapse. Over the past decades, many investigators have examined the role of various maintenance strategies in AML; with the intention to prolong remission and overall survival. This review will provide an overview of prior and ongoing approaches and strategies to maintenance therapy for AML.

Side‐by‐Side Comparative Study of a Moisturizer and Topical Tacrolimus for Treating Mild to Moderate Atopic Dermatitis: A Randomized Single‐Blinded Clinical Trial

The appropriate use of therapeutic moisturizers could reduce the need for more aggressive treatment in the management of atopic dermatitis (AD). We conducted a randomized, side‐by‐side, single‐blinded, comparative study in 41 mild to moderate AD patients to compare a moisturizer and topical tacrolimus for restoring skin barrier function and managing AD. A moisturizer was applied twice daily for 4 weeks to one side of the flexural areas (moisturizer group). Topical tacrolimus was applied on the other side of the tested area (tacrolimus group). Biophysical skin parameters were measured at baseline, week 2, and week 4. Clinical qualitative assessments were also conducted. Analysis of the trend from baseline to week 4 revealed that the hydration level was significantly increased in both groups (p &lt; 0.01, respectively). No biophysical parameters were significantly different between the two groups. Differences in the modified Eczema Area and Severity Index scores between the baseline and week 4 were significantly higher in the tacrolimus group than those in the moisturizer group (p = 0.002). In the Investigator’s Global Assessment, a significantly larger proportion of patients in the tacrolimus group showed clinical improvement than that in the moisturizer group at week 4 (p = 0.027). Although topical tacrolimus was superior to the moisturizer in preventing the clinical exacerbation of AD, the moisturizer was not inferior to topical tacrolimus in restoring skin barrier function. Therefore, moisturizer is considered to play an essential role in maintenance therapy for AD. Physicians need to emphasize the benefits of moisturizers when educating their patients.

The role of maintenance therapy in the treatment of advanced urothelial cancer: a comprehensive systematic review and network meta-analysis

Concerns increase with maintenance therapy for advanced urothelial cancer (aUC). We perform a comprehensive network meta-analysis (NMA) to investigate the efficacy and toxicities of maintenance therapy in aUC patients. Trials assessing maintenance treatment with either a continuous or a switch strategy for aUC were identified. The primary outcome was overall survival (OS), and secondary outcome was progression-free survival (PFS) and toxicities. Nine articles reporting eight trials were included. The pooled hazard ratio demonstrated that maintenance therapy significantly improved OS giving HR 0.83 (95%CI: 0.74–0.93, P = 0.0013) and PFS with HR of 0.78 (95%CI: 0.62–0.99, P = 0.05), but increased the risk of developing severe adverse events and treated-related discontinues (P < 0.05). Sub-group analysis indicated that ‘switch’ ICI (immune checkpoint inhibitor) maintenance therapy significantly improved OS and PFS when compared to best support care (BSC) (P < 0.05). NMA showed that chemotherapy followed by ‘switch’ maintenance with ICI significantly improved OS (HR 0.70, 95%CI: 0.57–0.87) when compared to BSC. ‘Continuous’ maintenance with ICI alone had a tendency to improve OS (HR 0.85, 95%CI: 0.71–1.01), and TA (HR0.93, 95%CI: 0.58–1.50) and vinflunine (HR 0.74, 95%CI: 0.44–1.24) was no significantly associated with a lower likelihood of disease death. Based on the analysis of the treatment ranking, ‘switch’ maintenance with ICI appeared as the best treatment approach. Our pooled results confirm that maintenance therapy yields a significant survival advantage for aUC patients. NMA indicates that switch maintenance with ICI is the optimum maintenance treatment for aUC and reduces mortality by about a third.

387P Maintenance treatment with cetuximab versus observation in RAS wild-type metastatic colorectal cancer: Final results of the randomized phase II TIME-PRODIGE 28 UNICANCER study

Although anti-EGFR monoclonal antibodies are active as single-agent therapy in RAS wild-type (wt) metastatic colorectal cancer (mCRC), few studies are available on their role in maintenance therapy during chemotherapy (CT)-free intervals (CFI).

Maintenance therapy for AML after allogeneic HCT.

Allogeneic hematopoietic cell transplant (allo-HCT) for eligible patients with acute myeloid leukemia (AML) in first complete remission is a central treatment paradigm to achieve durable remission. However, disease relapse after allo-HCT remains a significant concern and generally portends a poor prognosis. There is significant interest regarding the role for maintenance therapy after allo-HCT for patients with high risk of relapse, regardless of the presence of measurable residual disease. While there are currently no therapies approved for maintenance therapy for AML after allo-HCT, there are a number of ongoing investigations examining the role of maintenance therapies that include targeted agents against FLT3-ITD or IDH mutations, hypomethylating agents, immunomodulatory therapies and cellular therapies. In this review, we examine the current landscape and future strategies for maintenance therapy for AML after allo-HCT.

FLT3-targeted treatment for acute myeloid leukemia.

Mutations in the FMS-like tyrosine kinase 3 (FLT3) gene are detected in approximately 30% of acute myeloid leukemia (AML). The high frequency of FLT3 mutations, along with their adverse effect on prognosis, makes FLT3 a promising therapeutic target, and has spurred development of FLT3 inhibitors. First-generation inhibitors, including midostaurin and sorafenib, lack specificity for FLT3 and act on multiple kinases, whereas second-generation inhibitors, including gilteritinib, and quizartinib, are highly specific to FLT3 and are more potent than first-generation inhibitors. Several FLT3 inhibitors have recently gained regulatory approval worldwide, and several others are under development. The advent of FLT3 inhibitors has changed the standard treatment for FLT3-mutated AML in the frontline and relapsed/refractory settings and contributed to improved outcomes for this formidable AML subtype. However, numerous unresolved issues remain owing to rapid changes in practice. These include identification of optimum FLT3 inhibitors and combination therapies, the role of maintenance therapy, and the indication for allogeneic hematopoietic cell transplantation. Furthermore, strategies to overcome resistance to FLT3 inhibitors must be pursued. Results of ongoing and future studies will improve our ability to use FLT3 inhibitors more effectively, which should provide significant benefits to a wider range of patients.

Osteosarcoma/Ewing Sarcoma

Osteosarcoma/Ewing Sarcoma

Monoclonal Gammopathy of Ocular Significance (MGOS) - a Series of Corneal Manifestations and Treatment Outcomes

IntroductionMonoclonal gammopathy of ocular significance (MGOS) is a rare subset of monoclonal gammopathy of clinical significance (MGCS) occurring secondary to plasma cell dyscrasia resulting in ocular manifestations. Given the rarity of these conditions, optimal management strategies are not defined; the approach is dependent upon the underlying cause of the monoclonal gammopathy and whether or not the patient's vision is affected. We report our review of 23 cases with MGOS, more specifically on paraproteinemic keratopathy (PPK) the most common form, to obtain a better understanding of the patient characteristics, diagnosis and treatments.MethodsWe report an international retrospective series of patients with MGOS. Data was collected on patients with MGOS:there were no other inclusion criteria besides monoclonal gammopathy with an ophthalmologic manifestation; however, this report focuses only on patients with PPK. Efficacy outcomes were the hematologic and the ocular responses in patients with PPK. Hematologic responses were reported according to the IMWG response criteria. The ophthalmologic response to treatment was assessed by each contributing physician and reported as either complete, partial or no sight recovery.ResultsWe identified 23 patients with PPK in the setting of monoclonal gammopathy of unknown significance (MGUS), smoldering multiple myeloma (SMM), or multiple myeloma (MM) diagnosed between 2006 and 2019 in 7 countries. Table 1 summarizes the patients' characteristics. The ocular diagnosis was typically made at the same time or after the hematologic diagnosis. Eleven of 23 patients presented decreased vision. Four were treated by penetrating keratoplasty with or without systemic therapy, including chemotherapy with new generation anti-MM agents with or without autologous stem cell transplantation (ASCT). All patients with MM and 40% of those with other diagnoses such as SMM or MGUS received systemic therapy. In most cases, neither ocular nor hematologic treatment, even when ASCT was performed, afforded a durable improvement in the visual acuity despite initial responses. MGOS typically relapsed within one year of the initial response (Table 2).ConclusionTo date, this is the largest retrospective study focusing on MGOS patients with monoclonal immunoglobulin deposits accumulating in the cornea and resulting in visual impairment. Further studies will be required to determine the optimal strategy to treat and prevent the relapse of ocular symptoms in patients with PPK and specifically to address the timing of keratoplasty and systemic chemotherapy and the role of maintenance therapy. Patients with corneal manifestation of unknown origin should undergo a hematologic check-up and patients with paraproteinemia should have a periodic ocular health assessment. [Display omitted] DisclosuresGarderet: Takeda: Consultancy; Sanofi: Consultancy; Amgen: Consultancy; Janssen: Consultancy; Celgene: Consultancy. Munder: Janssen: Consultancy, Honoraria; BMS: Consultancy, Honoraria; Abbvie: Consultancy; Takeda: Consultancy, Honoraria; Amgen: Honoraria; Sanofi: Consultancy; GSK: Consultancy; Incyte: Research Funding. Gozzetti: AbbVie: Honoraria; Janssen: Honoraria. Rosinol: Janssen, Celgene, Amgen and Takeda: Honoraria. Jurczyszyn: Janssen-Cilag, Amgen: Honoraria, Speakers Bureau.

Maintenance therapy after second autologous hematopoietic cell transplantation for multiple myeloma. A CIBMTR analysis.

The role of maintenance therapy after high-dose chemotherapy and first autologous transplantation in multiple myeloma (MM) is well established. We explored the effect of maintenance therapy on outcomes after salvage second autologous hematopoietic cell transplant (AHCT2) using the Center for International Blood and Marrow Transplant Research registry. Outcomes of interest included non-relapse mortality (NRM), relapse/progression (REL), progression-free and overall survival (PFS, OS). Of 522 patients who underwent AHCT2 between 2010 and 2018, 342 received maintenance therapy and 180 did not. Maintenance regimens included lenalidomide (42%), pomalidomide (13%), and bortezomib (13%). Median follow up was 58 months in the maintenance group and 61.5 months in the no-maintenance group. Univariate analysis showed superior outcomes at 5 years in maintenance compared to the no-maintenance group: NRM 2 (0.7-3.9)% vs 9.9 (5.9-14.9)%, (p < 0.01), REL 70.2 (64.4-75.8)% vs 80.3 (73.6-86.3)% (p < 0.01), PFS 27.8 (22.4-33.5)% vs. 9.8 (5.5-15.2)% (p < 0.01), and OS 54 (47.5-60.5)% vs 30.9 (23.2-39.2)% (p < 0.01), respectively. Use of maintenance therapy retained its association with improved outcomes in multivariate analysis. There was no difference in second cancers in the two groups (p = 0.39). We conclude that maintenance after AHCT2 is associated with improved 5-year outcomes.

Primary central nervous system lymphoma in older adults and the rationale for maintenance strategies: a narrative review.

Objective:To provide a summary and analysis of the evidence for various agents applied as maintenance therapy and highlight ongoing trials or trials in development that evaluate the efficacy of maintenance therapy strategies in older patients with primary central nervous system lymphoma (PCNSL).Background:PCNSL are rare neoplasms that can have an aggressive course with short-lived remissions when compared to systemic diffuse large B-cell lymphoma (DLBCL). There is currently a paucity of evidence on treatment in older adults with PCNSL, who may be unfit to tolerate effective therapies for PCNSL. Those who can tolerate these therapies and survive PCNSL are at increased risk from developing treatment-related toxicity, functional decline, and debilitating neurotoxicity. While there is no clearly defined role for maintenance therapy after treatment of systemic DLBCL, it should be considered in PCNSL because central nervous system (CNS) recurrence often has a devastating and irreversible impact on neurologic function. Therefore, at least theoretically, use of effective maintenance therapy in older adults with PCNSL, either in lieu of consolidation or after consolidation therapy, may be better tolerated and help delay tumor progression, resulting in an improved overall global neurologic function and quality of life.Methods:We systematically searched MEDLINE (via PubMed) for all studies of drug treatments for maintenance therapy in PCNSL and also relied on expert opinion. We provide a summary and analysis of the evidence for various maintenance therapy agents, including methotrexate, rituximab, lenalidomide, temozolomide, ibrutinib, and procarbazine. We also highlight ongoing trials or trials in development that evaluate the efficacy of maintenance therapy in PCNSL.Conclusions:Prospective clinical studies focusing on PCNSL patients who are not candidates for intensive post-induction therapy are scarce. To date, there are no studies that clarify whether maintenance therapy can be used in lieu of consolidation therapy with autologous stem cell transplant or radiation. Prospective studies may provide critical data regarding the identification of optimal agents, whether consolidation therapy could be replaced by maintenance therapy, and the overall role of maintenance therapy as a means to potentially improve survival and preserve quality of life and function in a vulnerable, older patient population.

Progress in research: Daratumumab improves treatment outcomes of patients with AL amyloidosis.

Outcomes for patients with systemic light-chain (AL) amyloidosis have improved over the last two decades with timely diagnosis, use of novel chemotherapeutic agents, risk stratification and better patient selection criteria before hematopoietic autologous stem cell transplant (ASCT). However, majority of patients have advanced stage disease at initial presentation and at relapse rendering them ineligible for intensive cytotoxic chemotherapy or ASCT. Daratumumab (Dara) with or without standard chemotherapy appears to be an excellent treatment option for newly diagnosed and relapsed refractory AL amyloidosis. This is largely due to its tolerable safety and remarkable efficacy as seen in multiple retrospective, small phase II studies as well as a phase III randomized controlled trial. Here we review published clinical trials and retrospective data of Dara in AL amyloidosis that explore its role as a valuable addition to the treatment armamentarium for this challenging disease.

429P Maintenance treatment with cetuximab versus observation in RAS wild-type metastatic colorectal cancer: First results of the randomized phase II TIME-PRODIGE28 UNICANCER study according to RAS/BRAF status

Although anti-EGFR monoclonal antibodies are active as single-agent therapy in RAS wild-type (wt) metastatic colorectal cancer (mCRC), few studies are available on their role in maintenance therapy during chemotherapy (CT)-free intervals (CFI).