REFLECT: prospective multicenter non-interventional study evaluating the effectiveness and safety of Sandoz rituximab (SDZ-RTX; Rixathon®) in combination with CHOP for the treatment of patients with previously untreated CD20-positive diffuse large B-cell lymphoma

Background: REFLECT is the first prospective study of Sandoz biosimilar rituximab (SDZ-RTX) in patients with diffuse large B-cell lymphoma (DLBCL). Objective: To evaluate the 2-year effectiveness and safety of SDZ-RTX as first-line treatment for DLBCL. Design: Real-world, multicenter, open-label, single-arm, non-interventional, post-approval study of SDZ-RTX in combination with cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP) in patients with treatment-naïve CD20‑positive DLBCL. Methods: Treatment-naïve, CD20-positive adult patients (⩾18 years) with DLBCL eligible for therapy with R-CHOP were treated with SDZ-RTX-CHOP every 2 or 3 weeks for 6–8 cycles. The effectiveness of SDZ-RTX was measured by the complete response (CR) rate at the end of R-CHOP treatment, as assessed by the treating physician. Progression-free survival (PFS) was assessed at 24 months. Results: A total of 169 patients [52.1% female, median (range) age 70 (24−94) years] with DLBCL were included in the full analysis set. At baseline, 19.5% and 24.3% of patients had Ann Arbor disease stage III or IV, respectively, and most patients (80.5%) had Eastern Cooperative Oncology Group Performance Status of 0 or 1. A total of 100 (59.2%) patients completed the 24-month observation period. In total, 110 [65.1%; 95% confidence interval (CI): 57.4–72.3] patients achieved CR as best response and 50 (29.6%; 95% CI: 22.8–37.1) patients achieved partial response. Overall best response rate was 94.7% (95% CI: 90.1–97.5). One-year PFS was 84.9% (95% CI: 78.2–89.6), while 2-year PFS was 78.5% (95% CI: 70.9–84.4); median PFS was not reached within the observational period. A total of 143 (84.6%) patients experienced ⩾1 adverse event, 53 (31.4%) of which were suspected to be related to study drug. Conclusion: This real-world, 2-year study reconfirms that first-line treatment of CD20-positive DLBCL with R-CHOP using SDZ-RTX is effective and well tolerated

Early versus delayed tumor specific therapy and survival in patients with lung cancer:a retrospective study

INTRODUCTION: The timing of tumor specific palliative therapy and its influence on the survival of patients with stage IV lung cancer remains unclear.METHODS: 375 patients with stage IV lung cancer who experienced an early or delayed therapy (early or delayed therapy group; TG) were investigated using histology and ECOG performance score-related (ECOG-PS) subgroups. Kaplan-Meier and Cox regression analyses were used for survival analyses.RESULTS: Patients in the early TG had a significantly shorter median overall survival (OS) than those in the delayed TG (6 vs. 11 months). Patients with an ECOG-PS of ≥1 were significantly more present in the early than in the delayed TG (66.8% vs. 51.9%). But an early therapy was also significantly associated to a shorter median OS in ECOG-matched subgroups (ECOG-PS of 0; 7 vs. 23 months, ECOG &gt;1 ; 6 vs. 8 months). An early therapy was associated to a significantly worse median OS in histological subgroups (NSCLC; 5 vs. 11 months, SCLC; 7 vs. 11 months) and was an independent risk factor in uni- and multivariate analyses.CONCLUSIONS: An early initiation of cancer specific therapy was associated with a shorter survival time in palliative lung cancer patients, independent of the ECOG-PS and histological subtype.</p

Early versus delayed tumor specific therapy and survival in patients with lung cancer:a retrospective study

INTRODUCTION: The timing of tumor specific palliative therapy and its influence on the survival of patients with stage IV lung cancer remains unclear.METHODS: 375 patients with stage IV lung cancer who experienced an early or delayed therapy (early or delayed therapy group; TG) were investigated using histology and ECOG performance score-related (ECOG-PS) subgroups. Kaplan-Meier and Cox regression analyses were used for survival analyses.RESULTS: Patients in the early TG had a significantly shorter median overall survival (OS) than those in the delayed TG (6 vs. 11 months). Patients with an ECOG-PS of ≥1 were significantly more present in the early than in the delayed TG (66.8% vs. 51.9%). But an early therapy was also significantly associated to a shorter median OS in ECOG-matched subgroups (ECOG-PS of 0; 7 vs. 23 months, ECOG &gt;1 ; 6 vs. 8 months). An early therapy was associated to a significantly worse median OS in histological subgroups (NSCLC; 5 vs. 11 months, SCLC; 7 vs. 11 months) and was an independent risk factor in uni- and multivariate analyses.CONCLUSIONS: An early initiation of cancer specific therapy was associated with a shorter survival time in palliative lung cancer patients, independent of the ECOG-PS and histological subtype.</p

Early versus delayed tumor specific therapy and survival in patients with lung cancer:a retrospective study

INTRODUCTION: The timing of tumor specific palliative therapy and its influence on the survival of patients with stage IV lung cancer remains unclear.METHODS: 375 patients with stage IV lung cancer who experienced an early or delayed therapy (early or delayed therapy group; TG) were investigated using histology and ECOG performance score-related (ECOG-PS) subgroups. Kaplan-Meier and Cox regression analyses were used for survival analyses.RESULTS: Patients in the early TG had a significantly shorter median overall survival (OS) than those in the delayed TG (6 vs. 11 months). Patients with an ECOG-PS of ≥1 were significantly more present in the early than in the delayed TG (66.8% vs. 51.9%). But an early therapy was also significantly associated to a shorter median OS in ECOG-matched subgroups (ECOG-PS of 0; 7 vs. 23 months, ECOG &gt;1 ; 6 vs. 8 months). An early therapy was associated to a significantly worse median OS in histological subgroups (NSCLC; 5 vs. 11 months, SCLC; 7 vs. 11 months) and was an independent risk factor in uni- and multivariate analyses.CONCLUSIONS: An early initiation of cancer specific therapy was associated with a shorter survival time in palliative lung cancer patients, independent of the ECOG-PS and histological subtype.</p

Early versus delayed tumor specific therapy and survival in patients with lung cancer:a retrospective study

INTRODUCTION: The timing of tumor specific palliative therapy and its influence on the survival of patients with stage IV lung cancer remains unclear.METHODS: 375 patients with stage IV lung cancer who experienced an early or delayed therapy (early or delayed therapy group; TG) were investigated using histology and ECOG performance score-related (ECOG-PS) subgroups. Kaplan-Meier and Cox regression analyses were used for survival analyses.RESULTS: Patients in the early TG had a significantly shorter median overall survival (OS) than those in the delayed TG (6 vs. 11 months). Patients with an ECOG-PS of ≥1 were significantly more present in the early than in the delayed TG (66.8% vs. 51.9%). But an early therapy was also significantly associated to a shorter median OS in ECOG-matched subgroups (ECOG-PS of 0; 7 vs. 23 months, ECOG &gt;1 ; 6 vs. 8 months). An early therapy was associated to a significantly worse median OS in histological subgroups (NSCLC; 5 vs. 11 months, SCLC; 7 vs. 11 months) and was an independent risk factor in uni- and multivariate analyses.CONCLUSIONS: An early initiation of cancer specific therapy was associated with a shorter survival time in palliative lung cancer patients, independent of the ECOG-PS and histological subtype.</p

Early versus delayed tumor specific therapy and survival in patients with lung cancer:a retrospective study

INTRODUCTION: The timing of tumor specific palliative therapy and its influence on the survival of patients with stage IV lung cancer remains unclear.METHODS: 375 patients with stage IV lung cancer who experienced an early or delayed therapy (early or delayed therapy group; TG) were investigated using histology and ECOG performance score-related (ECOG-PS) subgroups. Kaplan-Meier and Cox regression analyses were used for survival analyses.RESULTS: Patients in the early TG had a significantly shorter median overall survival (OS) than those in the delayed TG (6 vs. 11 months). Patients with an ECOG-PS of ≥1 were significantly more present in the early than in the delayed TG (66.8% vs. 51.9%). But an early therapy was also significantly associated to a shorter median OS in ECOG-matched subgroups (ECOG-PS of 0; 7 vs. 23 months, ECOG &gt;1 ; 6 vs. 8 months). An early therapy was associated to a significantly worse median OS in histological subgroups (NSCLC; 5 vs. 11 months, SCLC; 7 vs. 11 months) and was an independent risk factor in uni- and multivariate analyses.CONCLUSIONS: An early initiation of cancer specific therapy was associated with a shorter survival time in palliative lung cancer patients, independent of the ECOG-PS and histological subtype.</p

PRECYCLE: multicenter, randomized phase IV intergroup trial to evaluate the impact of eHealth-based patient-reported outcome (PRO) assessment on quality of life in patients with hormone receptor positive, HER2 negative locally advanced or metastatic breast cancer treated with palbociclib and an aromatase inhibitor or palbociclib and fulvestrant

Background Efficacy and quality of life (QoL) are key criteria for therapy selection in metastatic breast cancer (MBC). In hormone receptor positive (HR +) human epidermal growth factor receptor 2 negative (HER2 −) MBC, addition of targeted oral agents such as everolimus or a cycline-dependent kinase 4/6 (CDK 4/6) inhibitor (e.g., palbociclib, ribociclib, abemaciclib) to endocrine therapy substantially prolongs progression-free survival and in the case of a CDK 4/6i also overall survival. However, the prerequisite is adherence to therapy over the entire course of treatment. However, particularly with new oral drugs, adherence presents a challenge to disease management. In this context, factors influencing adherence include maintaining patients’ satisfaction and early detection/management of side effects. New strategies for continuous support of oncological patients are needed. An eHealth-based platform can help to support therapy management and physician–patient interaction. Methods PreCycle is a multicenter, randomized, phase IV trial in HR + HER2 − MBC. All patients (n = 960) receive the CDK 4/6 inhibitor palbociclib either in first (62.5%) or later line (37.5%) together with endocrine therapy (AI, fulvestrant) according to national guidelines. PreCycle evaluates and compares the time to deterioration (TTD) of QoL in patients supported by eHealth systems with substantially different functionality: CANKADO active vs. inform. CANKADO active is the fully functional CANKADO-based eHealth treatment support system. CANKADO inform is a CANKADO-based eHealth service with a personal login, documentation of daily drug intake, but no further functions. To evaluate QoL, the FACT-B questionnaire is completed at every visit. As little is known about relationships between behavior (e.g., adherence), genetic background, and drug efficacy, the trial includes both patient-reported outcome and biomarker screening for discovery of forecast models for adherence, symptoms, QoL, progression free survival (PFS), and overall survival (OS). Discussion The primary objective of PreCycle is to test the hypothesis of superiority for time to deterioration (TTD) in terms of DQoL = “Deterioration of quality of life” (FACT-G scale) in patients supported by an eHealth therapy management system (CANKADO active) versus in patients merely receiving eHealth-based information (CANKADO inform). EudraCT Number: 2016–004191-2

A randomized phase III study evaluating pegylated liposomal doxorubicin versus capecitabine as first-line therapy for metastatic breast cancer: results of the PELICAN study

The PELICAN trial evaluates for the first time efficacy and safety of pegylated liposomal doxorubicin (PLD) versus capecitabine as first-line treatment of metastatic breast cancer (MBC). This randomized, phase III, open-label, multicenter trial enrolled first-line MBC patients who were ineligible for endocrine or trastuzumab therapy. Cumulative adjuvant anthracyclines of 360 mg/m(2) doxorubicin or equivalent were allowed. Left ventricular ejection fraction of > 50 % was required. Patients received PLD 50 mg/m(2) every 28 days or capecitabine 1250 mg/m(2) twice daily for 14 days every 21 days. The primary endpoint was time-to-disease progression (TTP). 210 patients were randomized (n = 105, PLD and n = 105, capecitabine). Adjuvant anthracyclines were given to 37 % (PLD) and 36 % (capecitabine) of patients. No significant difference was observed in TTP [HR = 1.21 (95 % confidence interval, 0.838-1.750)]. Median TTP was 6.0 months for both PLD and capecitabine. Comparing patients with or without prior anthracyclines, no significant difference in TTP was observed in the PLD arm (log-rank P = 0.64). For PLD versus capecitabine, respectively, overall survival (median, 23.3 months vs. 26.8 months) and time-to-treatment failure (median, 4.6 months vs. 3.7 months) were not statistically significantly different. Compared to PLD, patients on capecitabine experienced more serious adverse events (P = 0.015) and more cardiac events among patients who had prior anthracycline exposure (18 vs. 8 %;P = 0.31). Both PLD and capecitabine are effective first-line agents for MBC