Abstract Introduction Non-pegylated liposomal doxorubicin (NPLD) is considered a good alternative to conventional doxorubicin for the treatment of older patients (pts) with aggressive lymphomas and/or at high risk for cardiological toxicity. The use of R-COMP for the treatment of older pts with DLBCL has been supported by several small retrospective studies . In this report we describe the characteristics and outcomes of pts who were prospectively enrolled in the Elderly Project (EP) and who were treated with R-COMP and compared them with pts treated with conventional R-CHOP. Methods. This analysis was conducted starting from the dataset of the EP study. The use of NPLD was allowed according to 648/96 law, treatment decision was left to physician discretion and was independent of frailty status. For the purposes of this analysis, we included all pts who were treated with full doses of R-CHOP and R-COMP. The study endpoint were progression free survival (PFS) and overall survival (OS). A propensity score analysis was conducted to account for the main confounding factors. Results Overall 691 out of 1163 pts of the EP were treated with R-CHOP (383; 55%) or R-COMP (308; 45%); median age was 71 and 76 years for R-CHOP and R-COMP, respectively (p < 0.001) (Table 1). Pts were similarly distributed among different IPI groups for R-COMP or R-CHOP. Based on simplified Geriatric Assessment (sGA) 88%, 11% and <1% of the R-CHOP treated pts and 61%, 32% and 6% of the R-COMP pts were FIT, UNFIT, and FRAIL (p <0.001). Elderly Prognostic Index (EPI) score was low, intermediate, and high in 39%, 54% and 8% of R-CHOP pts and 27%, 49% and 24% of R-COMP pts (p <0.001). PFS at 3-years was 70% for R-CHOP and 64% for R-COMP (p=ns). OS at 3-years was 77% for R-CHOP and 71% for R-COMP (p=ns). The propensity score analysis was conducted in 610 pts and confirmed no significant differences in terms of PFS and OS in the comparison between R-CHOP and R-COMP treated pts (PFS; HR 1.17, 95% CI 0.84-1.63; OS: HR 1.04 95% CI 0.64-1.48). No differences were registered in terms of interruption of treatment due to toxicities (7% for R-CHOP and 11% for R-COMP). Conclusions Data from the prospective observational EP study did not show significant differences in terms of efficacy comparing R-COMP to standard R-CHOP. The higher frequency of UNFIT and FRAIL pts among those treated with NPLD suggests R-COMP is a good strategy to offer a curative treatment to these groups of pts. Figure 1 Figure 1. Disclosures Merli: EUSA Pharma: Other: Travel, Accomodations, Expenses; Roche: Membership on an entity's Board of Directors or advisory committees, Other: Travel, Accomodations, Expenses; Takeda: Membership on an entity's Board of Directors or advisory committees, Other: Travel, Accomodations, Expenses; MSD: Membership on an entity's Board of Directors or advisory committees; Gilead Science: Membership on an entity's Board of Directors or advisory committees, Other: Travel, Accomodations, Expenses; Janssen: Membership on an entity's Board of Directors or advisory committees, Other: Travel, Accomodations, Expenses; Celgene: Other: Travel, Accomodations, Expenses. Tucci: janssen: Membership on an entity's Board of Directors or advisory committees; Gentili: Membership on an entity's Board of Directors or advisory committees; Takeda: Membership on an entity's Board of Directors or advisory committees. Rigacci: Merck: Membership on an entity's Board of Directors or advisory committees; Abbvie: Membership on an entity's Board of Directors or advisory committees; Janssen: Membership on an entity's Board of Directors or advisory committees; Takeda: Membership on an entity's Board of Directors or advisory committees, Other: Travel, Accomodations, Expenses; Gilead Science: Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; Roche: Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; Menarini: Membership on an entity's Board of Directors or advisory committees; Celgene: Membership on an entity's Board of Directors or advisory committees, Speakers Bureau. Cavallo: ROCHE: Membership on an entity's Board of Directors or advisory committees; Servier: Speakers Bureau; Gilead: Speakers Bureau. Fabbri: Servier/Pfizer: Honoraria; Takeda: Other: Travel, Accomodations, Expenses; Takeda: Honoraria. Puccini: Takeda: Membership on an entity's Board of Directors or advisory committees. Ferrero: Incyte: Membership on an entity's Board of Directors or advisory committees; Morphosys: Research Funding; Gilead: Research Funding, Speakers Bureau; Janssen: Consultancy, Membership on an entity's Board of Directors or advisory committees, Research Funding, Speakers Bureau; EUSA Pharma: Consultancy, Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; Servier: Speakers Bureau; Clinigen: Membership on an entity's Board of Directors or advisory committees. Zilioli: Roche, Italfarmaco: Consultancy, Honoraria; MSD, Janssen: Consultancy, Membership on an entity's Board of Directors or advisory committees, Other: Travel, Accommodations; Gentili, Takeda, Gilead, Servier: Consultancy, Speakers Bureau; Takeda: Other: travel expenses, accommodation. Nassi: Takeda: Consultancy; Kyowa Kirin: Consultancy; Incyte: Consultancy; Roche: Consultancy. Musuraca: Janssen, Incyte, Roche: Consultancy; Janssen, Roche, Incyte: Membership on an entity's Board of Directors or advisory committees; Janssen, Roche, Incyte: Honoraria. Flenghi: Janssen: Other: Travel, Accomodations, Expenses; Roche: Other: Travel, Accomodations, Expenses. Marcheselli: sandoz: Membership on an entity's Board of Directors or advisory committees. Luminari: Roche: Consultancy, Membership on an entity's Board of Directors or advisory committees; Celgene: Consultancy, Membership on an entity's Board of Directors or advisory committees, Other: Travel, Accomodations, Expenses; Janssen: Other: Travel, Accomodations, Expenses; Gilead: Consultancy, Membership on an entity's Board of Directors or advisory committees; Regeneron: Consultancy; GENELAB SRL: Consultancy.
Introduction: The Elderly Prognostic Index (EPI) is based on the integration of a simplified geriatric assessment (sGA), haemoglobin levels, and International Prognostic Index (IPI) and has been validated to predict overall survival in older patients with Diffuse Large B-cell lymphoma (DLBCL) (Merli et al, JCO 2021). In this study we evaluated the ability of EPI to predict the risk of early mortality in older DLBCL patients. Methods: This analysis was conducted starting from the same dataset of the prospective observational Elderly Project (EP) that has been used to define the EPI. The main endpoint of this analysis was early mortality rate defined as death occurring within 90 days from the date of diagnosis. Starting from EP we only excluded alive patients with a follow-up shorter than 90 days. Clinical features, treatment details, and causes of death were retrieved from the EP dataset. Treatment was classified in three groups: Full Dose (FD; > 70% of theoretical dose of anthracycline), Reduced Dose (RD; < 70%), and Palliative therapy (PT; No anthracyclines). EPI was calculated as originally reported (Merli et al. JCO 2021) (Figure 1A). Results: This study was conducted on 1150 out of 1163 patients retrieved from the EP who were evaluable for the type of therapy and follow-up. Median age was 76 years (65 to 94). Thirty-one percent were older than 80 years; 55%, 28% and 17% were FIT, UNFIT , and FRAIL based on sGA. EPI score was 0-1 (low), 2-5 (intermediate), and 6-8 (high) in 24%, 48% and 28%, respectively. Time to Therapy (TTT) was shorter than 15 days in 24%. A pre-phase therapy was administered in 14% of patients but details were lacking. Overall, 69 early deaths were observed being 19% of all reported deaths. The cumulative incidence of early death at 90 days was 6.0%. Comparing the causes of the deaths occurring earlier or later than 90 days we observed lower frequency of deaths due to lymphoma progression for early events (42% vs 75%) and higher frequency of deaths due to toxicity and to infections (32% vs 4% and 22% vs 3%, respectively). In univariable analysis factors associated with higher risk of early deaths were age >80 years, sGA, anemia, high risk IPI, TTT < 15 days, bulky disease, EPI (intermediate and high risk) and the use of PT. We conducted a multivariable analysis on 931 patients excluding PT and confirmed an independent prognostic role to predict Early death for high risk EPI (OR 3.45; 95% CI 1.07–11.2) (Figure 1B) and for bulky disease (OR 2.09; 95% CI 1.09 – 3.98) The research was funded by: GRADE non profit foundation and UniCredit Bank Keywords: Diagnostic and Prognostic Biomarkers, Aggressive B-cell non-Hodgkin lymphoma, Therapeutics and Clinical Trials in Lymphoma - Other No conflicts of interest pertinent to the abstract.
Hairy cell leukemia (HCL) is a rare lymphoproliferative disease with specific morphologic and molecular features and excellent prognosis. Although high rate of complete response (CR) has been reported after treatment with purine analogs, expecially cladribine (2CDA), relapse may occur during follow-up. The aim of the study is to review the efficacy, safety, long term remission rate and overall survival (OS) in those patients (pts) that received 2CDA as first line treatment. We retrospectively reviewed data of all HCL pts treated with 2CDA between March 1991 and May 2019 at 18 Italian Hematological centers. Among 553 pts reported, only 513 were evaluable because treated with 2CDA alone. Considering the clinical carachteristics, M/F ratio was 4.5 with a median age of 54 years (range 24-88) and ECOG 0 in 85% of cases. Splenomegaly and presence of circulating hairy cells recorded by morphology were reported in 241 (47%) and 138 (27%) pts, respectively. Thirty-seven (7%) pts presented with an infection. Other comorbidities were cardiovascular in 29 (6%) pts, a previous cancer or diabetes in 27 (5%) each, chronic hepatic disorders in 18 (3%), obstructive pulmonary disease in 16 (3%), chronic kidney disease in 3 (1%). Three hundred-thirty (64%) pts received 2CDA intravenously (253 as daily continuous infusion for 5-7 consecutive days and 77 as weekly infusion for 5-7 consecutive weeks) and 183 (36%) subcutaneously. Response criteria were defined as per recent consensus guidelines (Grever MR et al. Blood 2017). The overall response rate (ORR) was 83%: CR in 335 pts (65%) and partial response (PR) in 96 (19%); 40 (8%) pts obtained hematological improvement (HI) and in 42 (8%) no response was observed. Nine of 11 (82%) pts with HI and 18/25 (72%) non responders who received salvage therapy obtained a major response (fig. 1). A slightly higher hemoglobin value (12.4 vs 11.4 g/dl, p=0.044), a reduced frequency of circulating hairy cells (28.7% vs 31.8%, p=0.039), absence of palpable splenomegaly (p=<0.001) and a faster recovery of ANC (28 days vs 41 days, p= 0.006) were associated with CR compared to PR in univariable analysis. No differences in terms of quality and duration of response, infection rate and time to blood counts recovery were reported according to the 2 routes of administration. Among pts receiving intravenous 2CDA, ORR was 85% for continuous infusion and 78% for weekly infusion: no statistically significant difference could be observed. Median duration of response was 12.2 years: 75.1%, 53.6% and 45.5% of responding pts are expected to be free from relapse at 5, 10 and 15 years, respectively. A statistically significant difference in duration of response was identified between pts that obtained a CR compared to pts in PR (19.4 years versus 4.7 years, p<0.0001) (fig. 2). No other differences in relapse free survival (RFS) were identified. Non-hematological grade-3 or higher early toxicity was reported in 108 (21%) pts, due to infections in 102 cases (20%), mainly fever of unknown origin and pneumonia. In 6 cases infection due to invasive aspergillosis, bacteric pneumonia and bacteric sepsis caused the death of pts. Other non-hematological adverse events were almost all grade-1 allergy (47 pts, 9%). No late toxicity was reported, but 19 (4%) second cancers were observed. Among 118 pts relapsed after a median of 4.4 years (fig. 1), 85 (72%) were retreated with 2CDA, alone (65 cases) or associated with rituximab (20 cases); 11 (9%) with pentostatin, alone (7 cases) or associated with rituximab (4 cases), 8 (7%) with interferon α, 8 (7%) with rituximab alone, 1 (1%) with vemurafenib and zanubrutinib each; 2 were lost at follow-up and 2 died before retreatment. Overall, 58 (51%) retreated pts obtained a CR (42 after 2CDA), 37 (32%) a PR (32 after 2CDA), 7 (6%) a HI (4 after 2CDA) and 12 (11%) did not show any response (6 after 2CDA). Median OS was not reached; 95.7%, 92.8% and 82.3% of pts are expected to be alive at 5, 10 and 15 years, respectively (fig. 2). Overall 51 pts died (10%), during the induction phase in 6 cases and during follow-up in 45: overall, mortality was HCL-related in 14 patients (2 progression of disease and 12 infections) and HCL-unrelated in 37 patients (cardiovascular events in 16, natural causes in 15, a second cancer in 6). 2CDA is greatly effective in treating HCL, with an ORR of 83%. Early and long term adverse events were rare and easily managed: although HCL-related mortality is still possible, OS at 15 years is higher than 80% Disclosures Motta: Roche: Honoraria; Janssen: Honoraria. Offidani:Celgene: Consultancy, Honoraria; Janssen: Consultancy, Honoraria; BMS: Consultancy, Honoraria. Tedeschi:Abbvie: Honoraria, Speakers Bureau; Sunesis: Honoraria, Speakers Bureau; Acerta: Honoraria, Speakers Bureau; Janssen: Honoraria, Speakers Bureau; Beigene: Honoraria, Speakers Bureau. Trentin:Janssen: Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding, Speakers Bureau; Abbvie: Honoraria, Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; Octapharma: Membership on an entity's Board of Directors or advisory committees; Takeda: Membership on an entity's Board of Directors or advisory committees; Shire: Honoraria. Varettoni:Roche: Consultancy, Membership on an entity's Board of Directors or advisory committees; AbbVie: Other: Travel/accommodations/expenses; Janssen: Consultancy, Membership on an entity's Board of Directors or advisory committees, Other: Travel/accommodations/expenses. Visentin:Janssen: Honoraria; Gilead: Honoraria; Abbvie: Honoraria. Falini:Roche: Research Funding. Pulsoni:Sandoz: Consultancy; Pfizer: Consultancy; Takeda: Consultancy; Gilead: Speakers Bureau; Bristol Myers Squibb: Speakers Bureau; roche: Consultancy, Speakers Bureau; Merk: Consultancy. Tiacci:Roche: Research Funding; Abbvie: Other: Travel and meeting expenses. Zinzani:Takeda: Honoraria, Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; Incyte: Honoraria, Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; Janssen: Consultancy, Honoraria, Speakers Bureau; Portola: Consultancy, Membership on an entity's Board of Directors or advisory committees, Research Funding, Speakers Bureau; Servier: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; ADC Therapeutics: Honoraria, Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; Kirin Kyowa: Honoraria, Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; Janssen-Cilag: Consultancy, Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; AbbVie: Honoraria, Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; Verastem: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; Sanofi: Consultancy, Membership on an entity's Board of Directors or advisory committees; Merck: Honoraria, Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; BMS: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; Gilead: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; Immune Design: Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; TG Therapeutics, Inc.: Honoraria, Speakers Bureau; Roche: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; Sandoz: Consultancy, Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; MSD: Consultancy, Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; Celltrion: Consultancy, Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; Celgene: Consultancy, Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; Eusapharma: Consultancy, Speakers Bureau; Kyowa Kirin: Consultancy, Speakers Bureau; Immune Design: Consultancy, Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; EUSA Pharma: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Speakers Bureau.
Follicular lymphoma (FL) is an indolent hematological disease, often responsive to the first line of treatment, but characterized by repeated relapses. The therapeutic algorithm for relapsed/refractory FL patients comprises phosphatidylinositol 3-kinase inhibitors. Idelalisib showed anticancer activity, while inducing a significant rate of toxicities. Since the evidence in the literature on its use in normal clinical practice is scarce, a retrospective multicenter study was conducted to evaluate effectiveness and tolerability in a real-life context. Seventy-two patients with a median age at diagnosis of 57.2 years—mostly with an advanced stage (88.9%) and relapsed to the most recent therapy (79.1%)—were enrolled. The median number of prior therapies was three (20.8% refractory to the last therapy before idelalisib). With a median number of 4 months of treatment, the overall response rate was 41.7% (20.8% complete responses). Median disease-free survival and overall survival were achieved at 8.4 months and at 4 years, respectively. Forty-four percent of patients experienced at least one drug-related toxicity: 6.9% hematological ones and 43% non-hematological. The study confirmed that idelalisib has anticancer effectiveness and an acceptable safety profile in relapsed/refractory FL with unfavorable prognostic characteristics, even in the context of normal clinical practice.
BACKGROUND:Relapsed or refractory (R/R) mantle-cell lymphoma (MCL) patients have a poor prognosis and their management is challenging, in absence of a golden standard as salvage treatment. Bruton's tyrosine kinase inhibitor ibrutinib represents an effective treatment for R/R MCL patients. We investigated ibrutinib efficacy and safety in daily clinical practice, together with factors that could predict disease outcome.PATIENTS AND METHODS:We retrospectively analyzed 69 consecutive R/R MCL patients managed in 10 Tuscan onco-hematological centers. The treatment regimen consisted of oral, continuous, single-agent ibrutinib, maximum dosage of 560 mg once per day, until disease progression.RESULTS:Overall response rate was 62.3%, with a CR rate of 39.1%. After a median follow-up of 15.6 months, 40/69 patients (58%) were alive, the main cause of death was progressive disease (PD, 22/69 cases, 31.9%). Median progression-free survival (PFS) and overall survival (OS) were 17 and 34.8 months. Inferior PFS was associated with >1 prior line of therapy and B symptoms. Ibrutinib refractoriness was associated with inferior OS, median OS after ibrutinib failure was only 5 months.DISCUSSION AND CONCLUSION:In this real-life setting ibrutinib treatment prolonged survival in R/R MCL patients, without unexpected adverse events. Patients receiving ibrutinib as 2nd line regimen had the most favorable outcome.
Introduction: Rituximab maintenance after frontline R+chemo prolongs remissions and is a widely adopted treatment option for patients with follicular lymphoma (FL). Moreover, metabolic and molecular response assessed with FDG-PET and MRD have been confirmed as strong predictors of patients’ survival thus suggesting the benefit of a response adapted maintenance strategy as post induction therapy. Methods: FOLL12 is a multicenter, randomized, phase III, non inferiority study comparing standard vs response adapted maintenance in patients with stage II-IV, previously untreated, intermediate-high risk FL according to FLIPI2, requiring therapeutic intervention. All patients received induction immunochemotherapy (ICT) with 6 cycles of R-CHOP or 6 cycles of R-bendamustine both followed by 2 additional doses of rituximab. After induction ICT, patients in the standard arm were treated with bimonthly rituximab doses for up to two years. Patients in the experimental arm were managed according to centrally reviewed metabolic and molecular response (i.e. Complete metabolic and molecular response: no therapy; Complete metabolic response without molecular response: 4 weekly rituximab doses; Lack of metabolic response (Deauville score 4-5): radiommunotherapy with ibritumomab tiuxetan followed by standard rituximab maintenance). Primary study endpoint was 3 years progression free survival (PFS) by intention to treat. A sample size of 770 evaluable patients was planned assuming a reference of 3yr PFS at 70% with a non inferiority margin of 7% between arms. Results: A total of 790 eligible patients were randomized to standard (394 patients) or experimental (396 patients) arm. Groups were well balanced according to patient characteristics and response rates. At the end of induction therapy 88% of cases resulted PET- and 91% MRD-. After a median follow-up of 37 months (range 1-71), the 3-year overall survival (OS) and PFS were 96% and 76%, respectively. An interim analysis, planned at the occurrence of 70% events, was anticipated at the occurrence of 50% of events and submitted to the external data safety monitoring committee (DSMC). The analysis showed that response oriented experimental arm resulted significantly inferior to the standard maintenance arm in terms of PFS (estimated 3-year PFS, 68% vs. 84%; hazard ratio for PFS, 2.05 [95% CI 1.50-2.81; P < 0.0001]). The DSMC considered unlikely that longer follow-up could modify the results and was favorable in publishing these data. Conclusions: In patients with intermediate-high risk FL according to FLIPI2 and requiring systemic therapy, omission of R-maintenance resulted in a significantly lower 3-year PFS, despite the attainment of a post-induction complete metabolic response. Keywords: follicular lymphoma (FL); minimal residual disease (MRD); positron emission tomography (PET). Disclosures: Federico, M: Honoraria: Janssen, Gilead, MedImmune. Mannina, D: Consultant Advisory Role: Janssen, AbbVie. Ferrero, S: Consultant Advisory Role: Janssen; Honoraria: Janssen, Gilead, Servier. Galimberti, S: Other Remuneration: Speaker for Roche, Takeda, Celgene, Janssen. Cavallo, F: Consultant Advisory Role: Takeda, Janssen. Arcaini, L: Consultant Advisory Role: CELGENE, SANDOZ, Janssen-Cilag, VERASTEM; Research Funding: Gilead. Chauvie, S: Honoraria: IAEA, CONSIP and Sirtex; Research Funding: Roche, Takeda, Fondazione Cassa di Risparmio di Cuneo and AIRC; Other Remuneration: Travel/accommodation from GE Healthcare, Philips Medical System, Sirtex, BTG, Terumo. He is co-founder of Dixit srl, spin-off of University of Torino and INFN. Rusconi, C: Consultant Advisory Role: Roche. Pinto, A: Consultant Advisory Role: Servier, Roche, Merck Sharp & Dohme; Honoraria: Roche/Genetech, Merck Sharp & Dohme, Bristol Myers Squibb, Celgene, Servier; Other Remuneration: EDO-Mundipharma (patenting process). Kovalchuk, S: Other Remuneration: Roche. Nassi, L: Consultant Advisory Role: Takeda, Janssen, MSD. Luminari, S: Consultant Advisory Role: Roche, Celgene, Sandoz, Gilead.
Background:Four cycles of ABVD followed by 30 Gy involved site radiotherapy (ISRT) is the standard of care for patients with early unfavourable classical Hodgkin lymphoma (cHL). Since dose‐density might represent an important factor to achieve complete remission and longterm survival, we designed a prospective, multicenter, phase II trial to investigate feasibility, safety and efficacy of dose‐dense ABVD (dd‐ABVD) in patients with early unfavourable HL. This prospective, multicentric, phase 2 study enrolled patients aged 18–70 years with newly diagnosed cHL, unfavourable stage I or II, according to EORTC prognostic criteria. Patients with stage IIB bulky were excluded.Aims:Aims of the study were to investigate feasibility, safety and efficacy of dd‐ABVD in patients with early unfavorable cHL.Methods:Dd‐ABVD consists of Doxorubicin, Bleomycin, Vinblastine and Dacarbazine used at the same doses of conventional ABVD but is administered on days 1 and 8 every 3 weeks instead of days 1 and 15 every 4 weeks. In the absence of progressive disease (PD) or unacceptable toxicity, 4 cycles of dd‐ABVD followed by ISRT were administered. Interim PET was mandatory after 2 courses (PET‐2). Patients experiencing PD were shifted to second‐line salvage therapy. Feasibility and activity of dd‐ABVD regimen were the primary endpoints of the study. By design, the study was considered feasible if ≤5 out of 52 patients required a dose reduction below 85% of the planned dose. The percentage of interim PET negativity was chosen as the parameter to evaluate its activity.Results:Between February 2012 and June 2015, 96 patients were enrolled and evaluated. The feasibility endpoint was achieved with only 4 out of 52 patients requiring a dose reduction greater than 15%. The mean dose intensity in the 96 patients who started dd‐ABVD treatment was 93.7% with only 3 patients unable to complete ddABVD chemotherapy due to toxicity. The activity analysis was performed in all 96 patients. PET‐2 was available for 92/96 (95.8%) patients, of whom 79 were PET‐2 negative (85.9%) and 13 PET‐2 positive (14.1%). In 3 cases PET‐2 was not performed due to logistic reasons and in 1 patient because of switch to standard ABVD following a SAE at cycle 1. Considering the global outcome of the 96 patients who received at least 1 dd‐ABVD course: 90 patients achieved CR (93.8 %), 1 PR (1%), 4 PD (4.2 %) and 1 (1%) was without a known disease assessment. With a median follow‐up of 39.9 months (range: 2.1‐ 57.6 months), median PFS and OS were not reached, at 24 months PFS and OS were 91.5% and 97.9%, respectively. No statistically significant differences were observed for PET‐2 negative and PET‐2 positive patients for both 2 years PFS (94.9% vs 84.6%, p: 0.260) and OS (98.7% vs 100% a, p: 0.560) (figure 1). Most frequent toxicities were haematological. The infection rate was low (infection 8.3% and febrile neutropenia 6.25%); no patient developed cardiac toxicity until now. There was one toxic death after cycle 4; 3 patients were discontinued from the study due to toxicity and were switched to standard ABVD or AVDSummary/Conclusion:The study demonstrates the feasibility of the dd‐ABVD regimen in early unfavourable cHL which also allows a reduction in overall treatment duration without a significant increase in toxicity. Moreover, the dose‐dense strategy translated in excellent data of outcome in term of CR rate, PFS, and OS with a low rate of progression at 2 years. Dd‐ABVD deserves further comparison with conventional ABVD in early unfavourable as well in advanced cHL.image
Here we report a rare case of concomitant pulmonary chondroid hamartoma and follicular non Hodgkin lymphoma in a 65-year-old woman with a history of 4-month nonspecific symptoms like fever, sweating and weight loss.