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- || Opdivo (nivolumab) / Ono Pharma, BMS
Clinical, Journal: Performance of Japanese patients in registrational studies. (Pubmed Central) - Jan 4, 2022
Early approvals were attained by either participating in the global registrational study or conducting a domestic phase II study. The higher efficacy of new agents may be an issue in the future, as Japanese patients had early access to the new agent and may receive better treatment after the trial.
- |||| Zykadia (ceritinib) / Novartis, Alecensa (alectinib) / Roche
Clinical, Real-world evidence: Assessment of Alectinib vs Ceritinib in ALK-Positive NSCLC in Phase 2 Trials and Real-world Data https://t.co/ozNJr9HFWn via @JAMANetworkOpen part of @JAMANetwork (Twitter) - Jan 2, 2022
- ECONOMIC IMPACT OF COMPASSIONATE USE OF CANCER TREATMENTS ([VIRTUAL]) - Dec 31, 2021 - Abstract #AIOM2021AIOM_248;
Despite its limitations this paper illustrates for the first time the net economic impact of CUP in oncology patients in the perspective of payers. Additional evaluations are ongoing to better understand the prospective effects of CUP implementation, i.e. the economic value of the comparative benefit profile of medicines used in CUP versus the SoC, including potential effects on indirect costs.
- Alecensa (alectinib) / Roche
A RETROSPECTIVE MULTICENTRE ANALYSIS OF RENAL EFFECT OF ALECTINIB IN ALK REARRANGED NON-SMALL CELL LUNG CANCER ([VIRTUAL]) - Dec 31, 2021 - Abstract #AIOM2021AIOM_117;
We reported a non-negligible incidence of renal impairment during alectinib; stabilization of renal function over time without cumulative effect support the hypothesis that the eGFR reduction may be related to a possible effect on tubular creatinine secretion rather than to a real nephrotoxicity. Renal function impairment may lead to treatment discontinuation or dose modification, thus in patients treated with ALK-I alternative methods for assessing renal function should be considered.
- || Xalkori (crizotinib) / Pfizer, Alecensa (alectinib) / Roche
Clinical, Journal: Clinical efficacy and safety of crizotinib and alectinib in ALK-positive non-small cell lung cancer treatment and predictive value of CEA and CA125 for treatment efficacy. (Pubmed Central) - Dec 28, 2021
Alectinib was clinically more efficacious and safer than crizotinib for ALK-positive NSCLC treatment. Both CEA and CA125 demonstrated excellent predictive value for treatment efficacy.
- || Alecensa (alectinib) / Roche
Biomarker, Clinical, Journal: Prognostic Markers of Survival among Japanese Patients with Anaplastic Lymphoma Kinase-Positive Non-Small-Cell Lung Cancer Receiving First-Line Alectinib. (Pubmed Central) - Dec 27, 2021
Immunological and nutritional markers could be useful in predicting the outcomes of first-line treatment with alectinib. Since PLR and SII consist of platelet counts, platelet count could be an important constituent of these markers.
- ||| Alecensa (alectinib) / Roche
Clinical: Some of these drugs have serum to CSF conc nearing 1:1. Alectinib is best eg w/identical syst and CNS RRates >80% and avg response dur’n approaching 2y. This is high and sustain response; pts would live to experience consequences of WBRT. Multidisc discussion needed w each case (Twitter) - Dec 27, 2021
- || Tagrisso (osimertinib) / AstraZeneca, Alecensa (alectinib) / Roche
Retrospective data, Review: Comparative Efficacy of Systemic Agents for Brain Metastases From Non-Small-Cell Lung Cancer With an EGFR Mutation/ALK Rearrangement: A Systematic Review and Network Meta-Analysis. (Pubmed Central) - Dec 27, 2021
All ALKi improved overall PFS compared to conventional chemotherapy, with alectinib having the greatest benefit (HR=0.13, 95%CI 0.07-0.24)...This data is important for treatment selection and patient counseling, and highlights areas for future RCT research. https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=179060.
- |||||||||| Rozlytrek (entrectinib) / Roche, Alecensa (alectinib) / Roche
Biomarker, New P3 trial, Metastases: A Study Evaluating the Efficacy and Safety of Multiple Therapies in Cohorts of Participants With Locally Advanced, Unresectable, Stage III Non-Small Cell Lung Cancer (NSCLC) (clinicaltrials.gov) - Dec 26, 2021
P3, N=320, Not yet recruiting, Sponsor: Hoffmann-La Roche
- || Lorbrena (lorlatinib) / Pfizer
Clinical, PK/PD data, Journal: Population Pharmacokinetic Model with Time-Varying Clearance for Lorlatinib using Pooled Data from Patients with Non-Small Cell Lung Cancer and Healthy Participants. (Pubmed Central) - Dec 25, 2021
Use of proton pump inhibitors was found to be a significant covariate on the lorlatinib absorption rate constant. These factors were assessed to have no clinically meaningful impact on lorlatinib plasma exposure, and no dose adjustments are considered necessary based on the examined covariates.
- || Clinical, Journal: Venous thromboembolism incidence and risk factors in non-small cell lung cancer patients receiving first-line systemic therapy. (Pubmed Central) - Dec 25, 2021
Treatment type and smoking status were predictive of time to VTE in NSCLC patients receiving various first-line therapies. Cumulative incidence was highest in those receiving TTs and combination chemotherapy plus ICI.
- ||| Tagrisso (osimertinib) / AstraZeneca
Biomarker, Enrollment change, Metastases: Phase 2 Platform Study in Patients With Advanced Non-Small Lung Cancer Who Progressed on First-Line Osimertinib Therapy (ORCHARD) (clinicaltrials.gov) - Dec 20, 2021
P2, N=210, Recruiting, Sponsor: AstraZeneca
Cumulative incidence was highest in those receiving TTs and combination chemotherapy plus ICI. N=150 --> 210
- || Tybost (cobicistat) / Gilead, Xalkori (crizotinib) / Pfizer
Clinical, Journal: Pharmacoenhancement of Low Crizotinib Plasma Concentrations in Patients with Anaplastic Lymphoma Kinase-Positive Non-Small Cell Lung Cancer using the CYP3A Inhibitor Cobicistat. (Pubmed Central) - Dec 16, 2021
Neither safety signals nor serious adverse events occurred. Pharmacoenhancement with cobicistat as an alternative for dose individualisation for patients with NSCLC with low crizotinib exposure appears to be safe and is cost-effective and feasible.
- || Review, Journal: Upfront Management of ALK-Rearranged Metastatic Non-small Cell Lung Cancer: One Inhibitor Fits All? (Pubmed Central) - Dec 16, 2021
During the past 10 years, multiple ALKi have been developed, and four different compounds are currently available as upfront options for ALK+ NSCLC patients: crizotinib, ceritinib, alectinib, and brigatinib...Among all available options, in our opinion, alectinib has likely the best profile of clinical activity and safety, thus emerging as the best upfront therapy. More insights will come from ongoing trials and analysis of biomarkers.
- || Alecensa (alectinib) / Roche
Biomarker, Clinical, Review, Journal: Is alectinib-induced elevation of creatine phosphokinase a predictive factor for response? Report of two cases and review of the literature. (Pubmed Central) - Dec 16, 2021
More insights will come from ongoing trials and analysis of biomarkers. A transient elevation of CPK and liver enzymes may take place during the alectinib treatment, indicating a tumor tissue damage thus contributing to a significant response.
- | Alecensa (alectinib) / Roche
Journal: Alectinib induces marked red cell spheroacanthocytosis in a near-ubiquitous fashion and is associated with reduced eosin-5-maleimide binding. (Pubmed Central) - Dec 16, 2021
Eosin-5-maleimide binding was reduced in all assessed patients, and increased membrane cholesterol was identified in one patient assessed with lattice light sheet microscopy. We have identified a previously undescribed phenomenon whereby alectinib induces red cell membrane abnormalities in nearly all patients through an unclear, but likely ALK-independent, mechanism, resulting in mild anaemia without universal haemolysis.
- ||| Clinical, Journal, Adverse events: Anaplastic lymphoma kinase tyrosine kinase inhibitor-induced hepatic failure in lung cancer patients: A study of signal mining and analysis of the FDA adverse event reporting system database. (Pubmed Central) - Dec 16, 2021
By mining the adverse event report signals in the FAERS database, we found the exposure event signals of AIHFEs in ALK TKIs were "hepatic failure," "hepatitis fulminant" and "hepatic necrosis". AIHFEs were more likely to appear in the reports of ceritinib, crizotinib and alectinib.
- || Alecensa (alectinib) / Roche
P2 data, Journal, IO biomarker: Blood First Assay Screening Trial (BFAST) in Treatment-Naïve Advanced or Metastatic Non-Small Cell Lung Cancer: Initial Results of the Phase 2 ALK-Positive Cohort. (Pubmed Central) - Dec 16, 2021
AIHFEs were more likely to appear in the reports of ceritinib, crizotinib and alectinib. These results demonstrate the clinical application of blood-based NGS as a method to inform clinical decision-making in ALK-positive NSCLC.
- ||| Journal, Adverse events: Pharmacovigilance analysis of cardiac toxicities associated with targeted therapies for metastatic non-small cell lung carcinoma. (Pubmed Central) - Dec 16, 2021
Osimertinib is strongly associated with QT prolongation, SVT, and heart failure relative to other EGFR inhibitors and targeted therapies. Monitoring for heart failure and arrhythmias should be considered with NSCLC targeted therapies, especially osimertinib.
- | New P2 trial, IO biomarker, Metastases: FINPROVE: The Finnish National Study to Facilitate Patient Access to Targeted Anti-cancer Drugs (clinicaltrials.gov) - Dec 15, 2021
P2, N=250, Not yet recruiting, Sponsor: Helsinki University Central Hospital
- |||| Avastin (bevacizumab) / Roche, Alecensa (alectinib) / Roche
P1/2 data: Congrats @JessicaJLinMD @JustinGainor @IbiayiMD @LeciaSequist @ilennes and the MGH Thoracic Oncology team for their article on the phase 1/2 investigator-initiated trial of alectinib plus bevacizumab in ALK+ lung cancer. (Twitter) - Dec 15, 2021
- Tagrisso (osimertinib) / AstraZeneca, Alecensa (alectinib) / Roche
Next Generation Sequencing (NGS) testing on Endobrochial Ultrasound – Guided Fine Needle Aspiration (EBUS-FNA) in Pap-Stained Smears: Results in Patients with Lung Adenocarcinoma (Poster Board Number: 18; LACC West Exhibit Hall A) - Dec 13, 2021 - Abstract #USCAP2022USCAP_1584;
Co-ocurring molecular alterations are frequent. Routine NGS testing in EBUS-FNA samples allows a comprehensive diagnosis (initial or after recurrence), increase targeted therapeutic options and better survival in lung ADC patients.
- |||| Zykadia (ceritinib) / Novartis, Alecensa (alectinib) / Roche
Clinical, Real-world evidence: Assessment of Alectinib vs Ceritinib in ALK-Positive NSCLC in Phase 2 Trials and Real-world Data https://t.co/je3sO12JPE via @JAMANetworkOpen part of @JAMANetwork (Twitter) - Dec 10, 2021
- || Tagrisso (osimertinib) / AstraZeneca
Biomarker, Trial completion date, Trial primary completion date, Metastases: Phase 2 Platform Study in Patients With Advanced Non-Small Lung Cancer Who Progressed on First-Line Osimertinib Therapy (ORCHARD) (clinicaltrials.gov) - Dec 7, 2021
P2, N=150, Recruiting, Sponsor: AstraZeneca
Routine NGS testing in EBUS-FNA samples allows a comprehensive diagnosis (initial or after recurrence), increase targeted therapeutic options and better survival in lung ADC patients. Trial completion date: May 2025 --> Nov 2025 | Trial primary completion date: May 2025 --> Nov 2025
- |||| Zykadia (ceritinib) / Novartis, Alecensa (alectinib) / Roche
Clinical, Real-world evidence: Assessment of Alectinib vs Ceritinib in ALK-Positive NSCLC in Phase 2 Trials and Real-world Data https://t.co/BEU3SYf03Q via @JAMANetworkOpen part of @JAMANetwork (Twitter) - Dec 6, 2021
- |||| Alecensa (alectinib) / Roche
Alectinib-2nd gen ALKi @Roche 🎯ALK & RET🎯 >>⬇️STAT2 & Akt Use in ALK+NSCLC (1st and 2nd line) See ALEX trial in the app, alect vs crizot by @peters_solange 💪CNS activity = ⬆️CNS toxicity Tox: Sinus brady ⬆️LFT=⬆️t-bili ILD🫁 ⬆️CPK=myalgia Rash,N/V/D (Twitter) - Dec 5, 2021
- |||| Zykadia (ceritinib) / Novartis, Alecensa (alectinib) / Roche
Clinical, Real-world evidence: Assessment of Alectinib vs Ceritinib in ALK-Positive NSCLC in Phase 2 Trials and Real-world Data https://t.co/y3IhYFge9x via @JAMANetworkOpen part of @JAMANetwork (Twitter) - Dec 5, 2021
- || Xalkori (crizotinib) / Pfizer, Alecensa (alectinib) / Roche
P2 data, Journal: Crizotinib for recurring non-small-cell lung cancer with EML4-ALK fusion genes previously treated with alectinib: A phase II trial. (Pubmed Central) - Nov 29, 2021
Trial completion date: May 2025 --> Nov 2025 | Trial primary completion date: May 2025 --> Nov 2025 Although the desired response rate was not achieved, crizotinib monotherapy following treatment with alectinib showed efficacy alongside previously described adverse events.
- || Alecensa (alectinib) / Roche
Clinical, Journal: Optimized Alectinib Dose Regimen for Treatment of Patients with ALK-Positive Non-Small Cell Lung Cancer Based on Robust Pharmacometric Analyses and Clinical Evidence. (Pubmed Central) - Nov 29, 2021
Although the desired response rate was not achieved, crizotinib monotherapy following treatment with alectinib showed efficacy alongside previously described adverse events. No abstract available
- || Alecensa (alectinib) / Roche
Clinical, Journal: Response to "Optimized Alectinib Dose Regimen for Treatment of Patients With ALK-Positive NSCLC Based on Robust Pharmacometric Analyses and Clinical Evidence". (Pubmed Central) - Nov 29, 2021
No abstract available No abstract available
- || Retrospective data, Review: Efficacy and Safety of First-Line Treatment Strategies for Anaplastic Lymphoma Kinase-Positive Non-Small Cell Lung Cancer: A Bayesian Network Meta-Analysis. (Pubmed Central) - Nov 29, 2021
Lorlatinib is associated with the highest PFS benefit and lowest risk of CNS progression benefits for patients with advanced ALK-positive NSCLC, compared with other first-line treatments, but with higher toxicity. The implementation of a newer generation of ALK-TKIs in the first-line treatment of ALK-positive NSCLC into current clinical practice is evolving rapidly.
- ||| Alecensa (alectinib) / Roche
Trial completion, Trial completion date, Trial primary completion date, Metastases: Treatment Registry of Alectinib in Anaplastic Lymphoma Kinase (ALK)-Positive, Locally Advanced or Metastatic Non-Small Cell Lung Cancer in Korea (clinicaltrials.gov) - Nov 26, 2021
P=N/A, N=355, Completed, Sponsor: Hoffmann-La Roche
The implementation of a newer generation of ALK-TKIs in the first-line treatment of ALK-positive NSCLC into current clinical practice is evolving rapidly. Active, not recruiting --> Completed | Trial completion date: Dec 2021 --> May 2021 | Trial primary completion date: Dec 2021 --> May 2021
- | Lorbrena (lorlatinib) / Pfizer, Alecensa (alectinib) / Roche
Journal: Alectinib and lorlatinib function by modulating EMT-related proteins and MMPs in NSCLC metastasis. (Pubmed Central) - Nov 25, 2021
Interestingly, in comparison to individual drugs, the combination of alectinib and lorlatinib was found to be substantially more effective. Overall, these results suggest that alectinib and lorlatinib possibly function via the downregulation of MMPs and EMT in NSCLC metastasis.
- Alecensa (alectinib) / Roche
Elucidating the Characteristics of Two Tumor Cell Populations in Small Cell Variant of Anaplastic Lymphoma Kinase-Positive Anaplastic Large Cell Lymphoma () - Nov 24, 2021 - Abstract #ASH2021ASH_6632;
Intriguingly, CD30-negative population behaved as chemo-resistant cells in clinical course, however alectinib, a second-generation ALK-inhibitor, eradicated both populations inducing first complete remission...The cause of distinct ALK staining levels in immunohistochemistry was revealed depending on the distinct expression level of NPM-ALK mRNA transcripts. Finally, since both populations were sensitive to ALK-inhibitor, early administration of ALK-inhibitor might be the reasonable option for SC-ALCL.
- || Biomarker, Clinical, Journal, Next-generation sequencing: Resistance profiles of anaplastic lymphoma kinase tyrosine kinase inhibitors in advanced non-small-cell lung cancer: a multicenter study using targeted next-generation sequencing. (Pubmed Central) - Nov 24, 2021
The mechanisms of ALK TKI resistance were heterogeneous; ALK mutations were found in less than one-third of patients. Compound ALK mutations, which may confer lorlatinib resistance, may occur in crizotinib, ceritinib, and alectinib-resistant lung cancers.
- |||| Zykadia (ceritinib) / Novartis, Alecensa (alectinib) / Roche
Clinical, Real-world evidence: Assessment of Alectinib vs Ceritinib in ALK-Positive NSCLC in Phase 2 Trials and Real-world Data https://t.co/GR9pGHTIvr via @JAMANetworkOpen part of @JAMANetwork (Twitter) - Nov 21, 2021
- || Jakafi oral (ruxolitinib) / Novartis, Incyte, Farydak (panobinostat) / Novartis, Alecensa (alectinib) / Roche
PK/PD data, Journal: Physiologically-Based Pharmacokinetic Model for Alectinib, Ruxolitinib, and Panobinostat in The Presence of Cancer, Renal Impairment, and Hepatic Impairment. (Pubmed Central) - Nov 17, 2021
The customized PBPK models showed promising ethical alternatives for simulating clinical studies in patients with cancer, RIP, and HIP. More work is needed to quantify other pathophysiological changes induced by simultaneous affliction by cancer and RIP or HIP.
- || Tagrisso (osimertinib) / AstraZeneca, Alecensa (alectinib) / Roche
👉🏼El #CancerdePulmon asocia ⬆️ morbilidad #CardiovascularDisease: 📍 ⬆️ tasa de #CAD y #FA, #anticoagulantes y #hemorragias secundarias 📍Enfermedad del pericardio: tumoral y tóxica 🧐#taponamiento 📍#cardiotox #Alectinib #ICI #Osimertinib #RT 📍 programas #cardioonc ayudan 💪🏼 (Twitter) - Nov 16, 2021
- |||| Zykadia (ceritinib) / Novartis, Alecensa (alectinib) / Roche
Clinical, Real-world evidence: Assessment of Alectinib vs Ceritinib in ALK-Positive NSCLC in Phase 2 Trials and Real-world Data https://t.co/SMX5OctcIw via @JAMANetworkOpen part of @JAMANetwork (Twitter) - Nov 14, 2021
- |||| Zykadia (ceritinib) / Novartis, Alecensa (alectinib) / Roche
Clinical, Real-world evidence: Assessment of Alectinib vs Ceritinib in ALK-Positive NSCLC in Phase 2 Trials and Real-world Data @oncoalert https://t.co/wWIT1pG7u0 via @JAMANetworkOpen part of @JAMANetwork (Twitter) - Nov 14, 2021
- ||| Xalkori (crizotinib) / Pfizer, Alecensa (alectinib) / Roche
Clinical, P3 data, Journal: Outcomes According to ALK Status Determined by Central IHC or FISH in Patients with ALK-Positive NSCLC Enrolled in the Phase III ALEX Study. (Pubmed Central) - Nov 11, 2021
Outcomes of patients with ALK IHC-positive/FISH-positive and ALK IHC-positive/FISH-uninformative NSCLC were similar to the overall ALEX population. These results suggest that Ventana ALK IHC is a standard testing method for selecting patients for treatment with alectinib.
- || Zykadia (ceritinib) / Novartis, Alunbrig (brigatinib) / Takeda, Alecensa (alectinib) / Roche
Clinical, P2 data, Journal: ALTA-2: Phase II study of brigatinib in patients with ALK-positive, advanced non-small-cell lung cancer who progressed on alectinib or ceritinib. (Pubmed Central) - Nov 10, 2021
The primary end point is confirmed objective response rate per independent review committee using response evaluation criteria in solid tumors version 1.1. Secondary end points include duration of response, progression-free survival, overall survival, safety and health-related quality of life.
- | Enrollment open, Tumor mutational burden: CRAFT: The NCT-PMO-1602 Phase II Trial (clinicaltrials.gov) - Nov 10, 2021
P2, N=175, Recruiting, Sponsor: German Cancer Research Center
Secondary end points include duration of response, progression-free survival, overall survival, safety and health-related quality of life. Not yet recruiting --> Recruiting
- || Alecensa (alectinib) / Roche
Clinical, Journal: Enteral administration of alectinib for ALK-positive non-small cell lung cancer in an elderly patient: A case report. (Pubmed Central) - Nov 7, 2021
Not yet recruiting --> Recruiting In cases of lung cancer with oncogenic addiction, enteral administration of TKIs should be considered for elderly patients with an impaired general condition.
- Xalkori (crizotinib) / Pfizer, Zykadia (ceritinib) / Novartis, Alecensa (alectinib) / Roche
ALK Inhibitor Plus Vinblasitine for Refractory/Relapsed Pediatric ALK+ Anaplastic Large Cell Lymphoma: A Prospective, One-Arm, Open-Label Real-World Study (GWCC - Hall B5, Level 1) - Nov 5, 2021 - Abstract #ASH2021ASH_2976;
Combination therapy may induce a more lasting remission in for patients without BM involvement. Patients with BM involvement are more likely to fail treatment.
- || Xalkori (crizotinib) / Pfizer, Alecensa (alectinib) / Roche
Clinical, Journal: A Case of Simultaneously Diagnosed Lung Adenocarcinoma and Endobronchial Inflammatory Myofibroblastic Tumor with Two Distinct Types of ALK Translocation. (Pubmed Central) - Nov 4, 2021
The patient was therefore received alectinib, and the tumor exhibited partly response. Overall, it is very rare that two types of pulmonary tumors exist in one patient driven by two distinct ALK fusions, which emphasizes the necessity of gene sequencing in clinical decision-making and individualized therapy.
- || Alunbrig (brigatinib) / Takeda
Biomarker, Clinical, Review, Journal, Next-generation sequencing: Sustained response to brigatinib in a patient with refractory metastatic pheochromocytoma harboring R1192P anaplastic lymphoma kinase mutation: a case report from the Austrian Group Medical Tumor Therapy next-generation sequencing registry and discussion of the literature. (Pubmed Central) - Oct 31, 2021
Therapy with the ALK inhibitor (ALKi) brigatinib led to dramatic and durable disease remission, despite previous disease progression on the ALKi alectinib. This case underscores the potential clinical use of molecular profiling in rare diseases with limited treatment options and suggests that the ALK-R1192P point mutation might predict sensitivity to brigatinib.
- [VIRTUAL] Toxicity and Local Control of Lung Stereotactic Body Radiation Therapy With or Without Concurrent Molecularly Targeted Therapies (McCormick Place West, Outside Room W375) - Oct 30, 2021 - Abstract #ASTRO2021ASTRO_1759;
Our results suggest that continuing TKI therapy during lung SBRT does not result in increased pulmonary toxicity. Thus, patients may not necessarily require a break from TKI treatment while undergoing SBRT, but more work will be required to assess the toxicities of each TKI in combination with radiation.
- Xalkori (crizotinib) / Pfizer, Retevmo (selpercatinib) / Eli Lilly, Alecensa (alectinib) / Roche
[VIRTUAL] Outcomes With Local Therapy and Tyrosine Kinase Inhibition in Patients With ALK/ROS1/RET-Rearranged Lung Cancers (McCormick Place West, Outside Room W375) - Oct 30, 2021 - Abstract #ASTRO2021ASTRO_1749;
Most common TKIs were alectinib (34), selpercatinib (17), and crizotinib (11). Local therapy for PD on ALK, ROS1 or RET TKIs was associated with clinically meaningful time on continued TKI therapy beyond progression.
- || Alecensa (alectinib) / Roche
Clinical, Journal: Successful Alectinib Treatment Administered by Mixing With a Soft Diet in a Patient With Non-Small-Cell Lung Cancer With Severe Dysphagia. (Pubmed Central) - Oct 30, 2021
Local therapy for PD on ALK, ROS1 or RET TKIs was associated with clinically meaningful time on continued TKI therapy beyond progression. No abstract available