Prolonging the platinum-free interval (PFI) with trabectedin to allow retreatment with platinum-based chemotherapy in patients with platinum-refractory and -resistant recurrent ovarian cancer (PROC).

2013 ◽  
Vol 31 (15_suppl) ◽  
pp. e16543-e16543
Author(s):  
Antonio Casado Herraez ◽  
Hector Callata ◽  
Aranzazu Manzano ◽  
Pluvio Coronado ◽  
Teresa Alonso ◽  
...  
Keyword(s):  
Clinical Benefit ◽  
Single Agent ◽  
Recurrent Ovarian Cancer ◽  
Platinum Resistance ◽  
Platinum Sensitive ◽  
Best Response ◽  
Platinum Based Chemotherapy ◽  
Sequential Treatments ◽  
A Minor ◽  
Platinum Agents

e16543 Background: Dose-dense therapy and administration of sequential non-platinum agents in PROC plays a role in reverting platinum-resistance and may improve the prognosis of such patients over years (Bamias A, 2013). The PFI extension is one of the current strategies to improve survival in partially platinum-sensitive (PPS) ROC, with a PFI 6-12 months (Poveda A, 2011). Trabectedin is a minor groove DNA-binder, which may play a role in reverting platinum resistance in patients with PROC and PPS ROC. Methods: Trabectedin 1.1-1.5 mg/m2as single agent was given as a 3-h infusion every 3 weeks with antiemetic and steroid premedication. Tumor response was assessed every 12 weeks. Results: Overall, 27 patients (24 with PROC and 3 with PPS ROC) treated from 2003 to 2013 in a single institution were included in the analysis. The patients had a median age of 63 years (range 45-81), most had serous-papillary (67%), clear-cell (11%), endometrioid (7%) and other (15%) histological subtypes and received a median of 5 prior chemotherapy lines (range: 1-9), 89% of whom also received other non-platinum agents. A median of 4.9 trabectedin cycles (range 1-14) was given. The overall response rate (ORR) was 15%, with a median duration of response of 16.5 weeks (range 5.86-44.43), while 41% of patients achieved stable disease (SD) lasting ≥4 months as best response. Thirteen of 27 patients were retreated with platinum-based chemotherapy after progression with trabectedin treatment. The ORR to platinum retreatment was 54% (n = 7) and SD was achieved in 8% (n = 1) of these patients, for an overall clinical benefit of 61%. Conclusions: Intercalation of a non-platinum therapy with trabectedin prior to subsequent platinum rechallenge may contribute to prolong PFI and to re-sensitize the patients with PROC and PPS ROC to further platinum-based therapies leading to a significant clinical benefit. Further prospective studies are warranted to determine the contribution of sequential treatments with trabectedin in patients with PROC and PPS ROC.

Phase II study of gemcitabine and oxaliplatin in patients with recurrent ovarian cancer: an Australian and New Zealand Gynaecological Oncology Group study

2007 ◽  
Vol 17 (2) ◽  
pp. 359-366 ◽  
Author(s):  
P. Harnett ◽  
M. Buck ◽  
P. Beale ◽  
A. Goldrick ◽  
S. Allan ◽  
...  
Keyword(s):  
Ovarian Cancer ◽  
Single Agent ◽  
Recurrent Ovarian Cancer ◽  
Ca 125 ◽  
Platinum Sensitive ◽  
Best Response ◽  
Platinum Based Chemotherapy ◽  
Group A ◽  
Intent To Treat ◽  
Group B

Gemcitabine and oxaliplatin have shown single-agent activity in relapsed ovarian cancer. This combination was used to determine response rates, time-to-event efficacy measures, and toxicity in patients with recurrent ovarian cancer. Patients with prior platinum-based chemotherapy who had measurable lesions and/or elevated CA-125 levels were identified as group A (platinum-refractory/platinum-resistant patients) and group B (platinum-sensitive patients). All patients received gemcitabine 1000 mg/m2 on days 1 and 8 and oxaliplatin 130 mg/m2 on day 8 every 21 days for up to eight cycles. Seventy-five patients (21 in group A and 54 in group B), with a median age of 58 years (range, 37–78), were enrolled. A median of six cycles (range, 1–8) was administered. By intent-to-treat analysis, 15 patients with measurable disease achieved partial response for an overall best response rate of 20.0% (9.5% in group A and 24.1% in group B). CA-125 response was observed in 48.4% patients (30.0% in group A and 57.1% in group B). Median time to progressive disease was 7.1 months (95% CI, 5.6–9.0 months) with 5.0 months in group A and 8.3 months in group B. Median overall survival was 17.8 months (95% CI, 12.9–21.3 months) with 9.2 months for group A and 20.0 months for group B. Major grade 3/4 toxicities were neutropenia (61.3%), leukopenia (24.0%), nausea (16.0%), and vomiting (22.7%). We conclude that the combination of oxaliplatin and gemcitabine is active in patients with recurrent ovarian cancer, but the regimen is unsatisfactory for further study due to modest response and relatively high toxicity.

Management of platinum-sensitive recurrent ovarian cancer (PSROC) in the era of biologics: Can ASCO’s net health benefits (NHB) inform our decisions?

2017 ◽  
Vol 35 (15_suppl) ◽  
pp. 5544-5544
Author(s):  
Jonathan Foote ◽  
Laura Jean Havrilesky ◽  
Elizabeth Lin Jewell ◽  
Charlotte Gamble ◽  
Jessie Ehrisman ◽  
...  
Keyword(s):  
Clinical Benefit ◽  
Liposomal Doxorubicin ◽  
Randomized Clinical Trials ◽  
Response Rate ◽  
Recurrent Ovarian Cancer ◽  
Cancer Therapies ◽  
Wild Type ◽  
Patient Centered ◽  
Platinum Sensitive ◽  
Platinum Based Chemotherapy

5544 Background: The ASCO value framework allows assessment of novel cancer therapies based on NHB. We assessed novel biologic therapies in the management of PSROC. Methods: ASCO’s revised value framework NHBs were constructed for key therapies based on randomized clinical trials for PSROC. BRCA-germline and HRD status were included. Additionally, patient-centered NHB calculations were weighted based on results from a prospective patient preferences study (n=54) and compared to ASCO-based NHB. Results: ASCO-centered NHB calculations were: platinum + taxane-based chemotherapy (ICON4) = 35; carboplatin + liposomal doxorubicin (CALYPSO) = 22; platinum-based chemotherapy + bevacizumab (OCEANS = 35; GOG 213 = 26). NHB scores based on germline-BRCA alterations were maintenance niraparib (NOVA) = 50 and maintenance olaparib (Study 19) = 62; wild-type BRCA, maintenance niraparib = 36 and maintenance olaparib = 33; and HRD-positive status, maintenance niraparib = 42. Patients valued clinical benefit as the most important component of NHB. Patients valued OS as the most important component of clinical benefit, followed by response rate (RR), then PFS. Patient-weighted NHB were significantly lower than ASCO-weighted scores (mean NHB 37.8 versus 23.5; p=0.009) due to decreased preference for PFS compared to other clinical benefit measures (Table). Conclusions: NHB scores for treatment of PSROC were highest in women with germline-BRCA and HRD tumor alterations who were treated with maintenance PARPi. Our data suggest that a patient-centered NHBs can be used to inform treatment decisions. [Table: see text]

Carboplatin hypersensitivity induced by low-dose paclitaxel/carboplatin in multiple platinum-treated patients with recurrent ovarian cancer

2005 ◽  
Vol 15 (2) ◽  
pp. 224-227 ◽  
Author(s):  
Y. Watanabe ◽  
H. Nakai ◽  
H. Ueda ◽  
K. Nozaki ◽  
H. Hoshiai
Keyword(s):  
Ovarian Cancer ◽  
Low Dose ◽  
Recurrent Disease ◽  
Recurrent Ovarian Cancer ◽  
Concentration Curve ◽  
Platinum Sensitive ◽  
Platinum Based Chemotherapy ◽  
Carboplatin Hypersensitivity ◽  
Third Line ◽  
Platinum Agents

We report five cases of carboplatin (CBDCA) hypersensitivity after weekly low-dose paclitaxel (60 mg/m2)/CBDCA (area under the concentration curve = 2) therapy in patients with recurrent ovarian cancer receiving multiple platinum-based chemotherapy. Paclitaxel and CBDCA therapy was indicated as second-line chemotherapy in one patient and as third line in four patients with recurrent disease. The range of previously administered total CBDCA was 2582–9589 mg, and the CBDCA area under the concentration curve of the first treatment exhibited appropriate intensity (mean, 1.92 ± 0.10; range, 1.76–2.10) in all patients. However, one patient exhibited severe hypersensitivity reactions including cardiac arrest and apnea, and another four patients developed eruptions, hypotension, and tachycardia soon after administration of CBDCA. Our report suggested that CBDCA hypersensitivity was correlated with the total dose of previously administered platinum agents and that CBDCA should be excluded in patients who have received multiple platinum-based chemotherapy, even in platinum-sensitive cases, because CBDCA hypersensitivity can occur even with low-dose CBDCA administration.

Dora: A randomized phase II multicenter maintenance study of olaparib alone or olaparib in combination with durvalumab in platinum responsive advanced triple-negative breast cancer (aTNBC).

2019 ◽  
Vol 37 (15_suppl) ◽  
pp. TPS1113-TPS1113
Author(s):  
Sarah Sammons ◽  
Tira Jing Ying Tan ◽  
Tiffany A. Traina ◽  
Sung-Bae Kim ◽  
Young-Hyuck Im ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Ovarian Cancer ◽  
Maintenance Therapy ◽  
Phase Ii ◽  
Clinical Benefit ◽  
Single Agent ◽  
Phase Iii ◽  
Parp Inhibition ◽  
Platinum Sensitive ◽  
Platinum Based Chemotherapy

TPS1113 Background: PARP inhibition (PARPi) with olaparib is approved in HER2-negative germline BRCA mutant (g BRCAm) metastatic breast cancer. Maintenance PARPi in relapsed platinum-sensitive ovarian cancer improves median PFS regardless of gBRCA mutation status. Preclinical work has shown that platinum response strongly correlates with olaparib response in breast cancer models; hence, maintenance therapy trials are underway in aTNBC. PARPi modulates immune responses and enhances immunogenicity in many preclinical models. We hypothesize that olaparib either alone or in combination with the PD-L1 inhibitor durvalumab will have clinical efficacy as maintenance therapy in aTNBC subjects who have responded to platinum-based chemotherapy. Methods: DORA is a randomized, international, multicenter, phase II study designed to explore the efficacy of olaparib or olaparib in combination with durvalumab as maintenance therapy in platinum-sensitive aTNBC. 60 subjects will be enrolled following a minimum of 3 cycles of treatment with platinum-based (cisplatin or carboplatin) chemotherapy as a single agent or combination therapy in the first or second-line setting. Subjects deriving clinical benefit (CR / PR / SD) from platinum-based therapy will be eligible and randomized in a 1:1 ratio. Patients in arm 1 will receive olaparib orally 300mg BID continuously and in arm 2 will receive olaparib orally 300mg BID continuously in combination with durvalumab 1500mg IV every 4 weeks. Assessment of tumor response will be done every 8 weeks. Primary endpoint: progression-free survival. Secondary endpoints: overall survival, clinical benefit rate, safety. Correlative analyses: pre-treatment archival/fresh biopsy samples are mandated. Post-treatment tissue biopsy is requested. Serial ctDNA will be collected at baseline, staging, and progression to correlate with response and track emerging genomic alterations in a platinum sensitive cohort under the pressure of PARP inhibition. Whole exome DNA sequencing, IHC for PDL-1 and TILs will be performed on tissue samples. ClincalTrials.gov Identifier: NCT03167619. (Moore K, et al "SOLO-1: Phase III trial of maintenance olaparib following platinum-based chemotherapy in newly diagnosed patients with advanced ovarian cancer and a BRCA1/2 mutation" ESMO 2018; Abstract LBA7-PR). Clinical trial information: NCT03167619.

Efficacy of anti-PD(L)1 therapy for patients (Pts) with advanced urothelial carcinoma (aUC) with primary resistance to platinum-based chemotherapy (PC).

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. e16515-e16515
Author(s):  
Tyler F. Stewart ◽  
Nikhil V. Kotha ◽  
Hannah Elizabeth Dzimitrowicz ◽  
Dimitrios Makrakis ◽  
Ali Raza Khaki ◽  
...  
Keyword(s):  
Metastatic Disease ◽  
Cox Regression ◽  
Single Agent ◽  
Objective Response ◽  
Locoregional Therapy ◽  
High Risk Population ◽  
Primary Resistance ◽  
Best Response ◽  
Platinum Based Chemotherapy ◽  
Line Of Therapy

e16515 Background: PC remains standard first-line (1L) therapy for aUC. Approximately 15% of pts exhibit primary resistance (P-R) to PC and ∼25% progress by 4 months. PD(L)1 inhibitors yield objective response rates (ORR) of ∼20% in pts with progression after PC; however, it is unclear if this benefit extends to pts with P-R to PC. We examined the efficacy of anti-PD(L)1 in pts with aUC who experienced P-R to 1L PC. Methods: We conducted a multi-institutional retrospective study of pts with aUC who experienced P-R to PC and were subsequently treated with single-agent anti-PD(L)1 therapy. Eligibility included pts with unresectable or metastatic disease diagnosed after January 1, 2017. P-R to PC was defined as radiographic progression by RECISTv1.1 within 12 weeks from initiation of PC. Pts who developed metastatic disease while receiving (neo)adjuvant PC were eligible. Clinicopathologic variables were collected. ORR to anti-PD(L)1 was the primary endpoint. Secondary endpoints included time to treatment failure (TTF, defined as time from start of anti-PD(L)1 therapy to next line of therapy, hospice or death) and overall survival (OS) were estimated using Kaplan-Meier method. Multivariate (MV) analysis using Cox regression evaluating factors associated with OS was performed. Results: Overall, 42 pts were included: 74% male, median age 65 (28-90); 79% ever smokers; 21% mixed histology; 31% received definitive locoregional therapy. Metastatic sites at diagnosis of aUC included: lymph node only (19%), liver (29%), bone (38%) and lung (33%). At diagnosis of aUC, ECOG PS was 0 in 26%, 1 in 52% and unknown in 21%. 1L PC included cisplatin (76%) and carboplatin (24%) based regimens. Anti-PD(L)1 was received either 2L (98%) or 3L (2%). Overall, ORR to anti-PD(L)1 was 17%: CR (2%), PR (14%), SD (14%), PD (57%) and unknown (12%). Of the 24 pts with PD as best response to anti-PD(L)1, only 9 (38%) received subsequent therapy. Overall, median TTF was 4.2 mo (95% CI 2.8-6.7 mo) and median OS was 7.4 mo (95% CI 4.2-11.1 mo). ORR in patients with a PDL1 combined positive score ≥ 10% (n=6) was 0%: 1 SD and 5 PD. MV analysis for OS from start of anti-PD(L)1 is shown (Table). Conclusions: P-R to PC portends a poor prognosis in pts with aUC. While a subset of patients may respond to anti-PD(L)1 therapy, the majority of pts do not derive benefit. Alternative agents, e.g. antibody drug conjugates and FGFR inhibitors, and combination-therapy should be investigated for this high risk population.[Table: see text]

A phase Ib/II study of selinexor in combination with imatinib in patients with advanced gastrointestinal stromal tumor (GIST): SeliGIST/GEIS-41 trial.

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. 11534-11534
Author(s):  
Cesar Serrano ◽  
Claudia Valverde ◽  
Josefina Cruz Jurado ◽  
Javier Martinez-Trufero ◽  
Xavier Guri ◽  
...  
Keyword(s):  
Clinical Benefit ◽  
Nuclear Export ◽  
Single Agent ◽  
Progression Free Survival ◽  
Antitumoral Activity ◽  
Clinical Activity ◽  
Activity Data ◽  
Phase Ib ◽  
Best Response ◽  
Heavily Pretreated

11534 Background: KIT or PDGFRA oncogenic activation drives GIST progression throughout the disease course. Accordingly, currently approved agents in metastatic GIST focus on the therapeutic suppression of these receptors. However, the clinical benefit after imatinib (IM) progression is still modest, suggesting the co-operation of KIT/PDGFRA-independent mechanisms in GIST cell survival. Selinexor is an oral, selective inhibitor of XPO1-mediated nuclear export, and preclinical studies evidenced antitumoral activity in GIST as single agent and in combination with IM in both IM-sensitive and IM-resistant models. Methods: The phase Ib portion studied IM 400 mg daily plus weekly selinexor in patients (pts) with IM-resistant, advanced GIST. Prior intolerance to IM was not allowed. A standard 3+3 dosing schema was utilized to determine the recommended phase II dose (RP2D) of this combination. Investigator-assessed response was evaluated every 8 weeks using RECIST 1.1. Results: At data cutoff of Sep 25, 2020, 12 pts were enrolled and received treatment with IM 400 mg and selinexor once weekly at dose levels (DL) 1 (60 mg), DL2 (80 mg) and DL3 (100 mg). Median age 57 (range 46-77), 42% female, median prior therapies 4 (range 2-7). Although only 1/6 pts developed a dose limiting toxicity (DLT) at DL3, the RP2D was defined at DL2 (IM 400 mg daily and selinexor 80 mg once weekly) based on activity data in the DL2 and the need for dose reductions in 5/6 pts at DL3 after the DLT window. All pts were evaluable for toxicity and response. One DLT occurred at DL3 (G3 nausea). Non-DLT G3/4 toxicities were anemia (1/12 pts), neutropenia (1/12 pts), vomiting (1/12 pts) and fatigue (2/12 pts). Common G1/2 toxicities were nausea (11/12 pts), vomiting (10/12 pts), neutropenia (5/12 pts) and anemia, fatigue, diarrhea, and periorbital edema (4/12 pts each). No unexpected toxicities were observed. Overall response rate in the 12 pts evaluable for response was 67% (95% CI 0.349-0.901), with 2 pts achieving PR (17%) and 6 pts SD (50%) as the best response. Clinical benefit rate (CBR = CR, PR, SD) ≥ 16 weeks was 42% (95% CI 0.157-0.723). Median progression free survival was 3.5 months (95% CI 1.7-7.3). Four pts remain on trial at data cutoff. Conclusions: IM and selinexor combination is well-tolerated and has clinical activity in heavily pretreated GIST pts. The trial is currently exploring selinexor as single agent in the IM-resistant GIST population. Clinical trial information: NCT04138381.

scholarly journals Novel epigenetic-metabolic inhibitor combination treatment blocks platinum-induced ovarian cancer stem cell enrichment

2021 ◽  
Author(s):  
Riddhi Sood ◽  
Sikai Xiao ◽  
Shruthi Sriramkumar ◽  
Christiane Hassel ◽  
Kenneth P. Nephew ◽  
...  
Keyword(s):  
Ovarian Cancer ◽  
Recurrent Ovarian Cancer ◽  
Dna Methyltransferases ◽  
Metabolic Inhibitor ◽  
Platinum Resistance ◽  
Dna Hypermethylation ◽  
Ovarian Cancer Stem Cells ◽  
Promoter Dna ◽  
Rate Limiting ◽  
Platinum Agents

AbstractHigh grade serous ovarian cancer (HGSOC) is the most common and aggressive type of ovarian cancer. Platinum resistance is a common occurrence in HGSOC and a main cause of tumor relapse resulting in high patient mortality rates. Recurrent ovarian cancer is enriched in aldehyde dehydrogenase (ALDH)+ ovarian cancer stem cells (OCSCs), which are resistant to platinum agents. We demonstrated that acute platinum treatment induced a DNA damage-dependent decrease in BRCA1 levels throughBRCA1promoter DNA hypermethylation. In a parallel pathway associated with G2/M arrest, platinum treatment also induced an increase in expression ofNAMPT, the rate limiting regulator of NAD+production from the salvage pathway, and NAD+levels, the cofactor required for ALDH activity. Both decreased BRCA1 and increased NAD+levels were required for the platinum-induced enrichment of OCSCs, and inhibition of both DNA methyltransferases (DNMT) and NAMPT synergistically abrogated the platinum-induced increase in OCSCs. We conclude that these two separate pathways lead to platinum-induced OCSC enrichment, providing preclinical evidence that in the neoadjuvant setting, combining DNMT and NAMPT inhibitors with platinum has the potential to reduce OC reoccurrence.

scholarly journals Development of a Genomic Signatures-Based Predictor of Initial Platinum-Resistance in Advanced High-Grade Serous Ovarian Cancer Patients

2021 ◽  
Vol 10 ◽  
Author(s):  
Yuan Li ◽  
Xiaolan Zhang ◽  
Yan Gao ◽  
Chunliang Shang ◽  
Bo Yu ◽  
...  
Keyword(s):  
Ovarian Cancer ◽  
Predictive Accuracy ◽  
Predictive Performance ◽  
Platinum Resistance ◽  
High Grade ◽  
Serous Ovarian Cancer ◽  
Single Nucleotide Variants ◽  
Tissue Samples ◽  
Platinum Sensitive ◽  
Platinum Based Chemotherapy

BackgroundHigh grade serous ovarian cancer (HGSOC) is the most common subtype of ovarian cancer. Although platinum-based chemotherapy has been the cornerstone for HGSOC treatment, nearly 25% of patients would have less than 6 months of interval since the last platinum chemotherapy, referred to as platinum-resistance. Currently, no precise tools to predict platinum resistance have been developed yet.MethodsNinety-nine HGSOC patients, who have finished cytoreductive surgery and platinum-based chemotherapy in Peking University Third Hospital from 2018 to 2019, were enrolled. Whole-genome sequencing (WGS) and whole-exome sequencing (WES) were performed on the collected tumor tissue samples to establish a platinum-resistance predictor in a discovery cohort of 57 patients, and further validated in another 42 HGSOC patients.ResultsA high prevalence of alterations in DNA damage repair (DDR) pathway, including BRCA1/2, was identified both in the platinum-sensitive and resistant HGSOC patients. Compared with the resistant subgroup, there was a trend of higher prevalence of homologous recombination deficiency (HRD) in the platinum-sensitive subgroup (78.95% vs. 47.37%, p=0.0646). Based on the HRD score, microhomology insertions and deletions (MHID), copy number changes load, duplication load of 1–100 kb, single nucleotide variants load, and eight other mutational signatures, a combined predictor of platinum-resistance, named as DRDscore, was established. DRDscore outperformed in predicting the platinum-sensitivity than the previously reported biomarkers with a predictive accuracy of 0.860 at a threshold of 0.7584. The predictive performance of DRDscore was validated in an independent cohort of 42 HGSOC patients with a sensitivity of 90.9%.ConclusionsA multi-genomic signature-based analysis enabled the prediction of initial platinum resistance in advanced HGSOC patients, which may serve as a novel assessment of platinum resistance, provide therapeutic guidance, and merit further validation.

scholarly journals Maintenance with Trabectedin in the Treatment of Platinum-Sensitive Recurrent Ovarian Cancer

2019 ◽  
Vol 12 (2) ◽  
pp. 447-455 ◽  
Author(s):  
Eva María Guerra Alía ◽  
Cayetano Sempere Ortega ◽  
Alfonso Cortés Salgado ◽  
Concepción Sanchez Martínez ◽  
Julio Galindo Álvarez ◽  
...  
Keyword(s):  
Ovarian Cancer ◽  
Pegylated Liposomal Doxorubicin ◽  
Abdominal Distension ◽  
Recurrent Ovarian Cancer ◽  
Response To Treatment ◽  
Case Presentation ◽  
Good Tolerance ◽  
Platinum Sensitive ◽  
Platinum Based Chemotherapy ◽  
Selection Of

Ovarian cancer is the seventh most common type of cancer and the fifth leading cause of cancer death among women worldwide. The current usual therapeutic approach in this disease includes optimal cytoreductive therapy followed by platinum-based adjuvant chemotherapy, along with neoadjuvant chemotherapy prior to surgery in selected cases. The platinum-free interval (PFI) continues to be the most useful tool to assist in the selection of the subsequent therapy and to predict response to treatment. The combination of trabectedin and pegylated liposomal doxorubicin (PLD) is useful in patients with partially platinum-sensitive recurrent ovarian cancer, in patients who have previously received two or more platinum-based chemotherapy regimens, in patients who have already experienced a platinum-induced hypersensitivity reaction and in patients who have previously failed to respond to a platinum-based treatment. Case Presentation: A 64-years-old postmenopausal woman with pain, abdominal distension, and an altered intestinal transit and with partially platinum-sensitive recurrent ovarian cancer, was successfully treated with a second line of trabectedin chemotherapy in combination with PLD, followed by trabectedin in monotherapy. This case proves the effectiveness of the combination of trabectedin and PLD and demonstrates how the administration of trabectedin, even in monotherapy, allows to maintain an adequate clinical response with good tolerance to the treatment during more than two years of drug administration.

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