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Dolores Isla
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ES14 - What First Line in Oncogene Addicted NSCLC (ID 17)
- Event: WCLC 2019
- Type: Educational Session
- Track: Targeted Therapy
- Presentations: 5
- Now Available
- Moderators:Dolores Isla, Jessica Menis
- Coordinates: 9/08/2019, 15:15 - 16:45, Vancouver (2003)
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ES14.01 - First Line in EGFR Mutated Patients (Now Available) (ID 3230)
15:15 - 16:45 | Presenting Author(s): Thanyanan Reungwetwattana
- Abstract
- Presentation
Abstract
Precision medicine is currently applied for almost all cancer types, especially, in NSCLC which is the prototype of successful targeted therapy. Epidermal growth factor receptor tyrosine kinase inhibitor (EGFR-TKI) is the first effective targeted drug found in NSCLC for treatment in EGFR-mutation positive patients. EGFR (also termed human epidermal growth factor receptor 1 [HER1] or ErbB1) is a member of the ErbB family of cell surface receptor tyrosine kinase1. It is a 170‑kDa RTK with an extracellular ligand‑binding domain, a transmembrane region and an intracellular tyrosine kinase. The RTKs form homodimers and heterodimers after binding to specific ligands, leading to autophosphorylation of tyrosine residues on the intracellular TK domain. This interaction recruits a diverse set of signal transduction cascades including the phosphoinositide 3‑kinase (PI3K)/protein kinase B (AKT)/ mammalian target of rapamycin (mTOR), signal transduction and transcription (STAT) transcription and RAS/RAF/ mitogen‑activated protein kinase (MAPK) proliferation pathway1. In 2004, somatic mutations in the TK domain of EGFR, found most frequently in adenocarcinomas from patients in Asia who were never or former smokers, were strongly correlated with sensitivity to EGFR-TKIs1. The prevalence of EGFR mutation in NSCLC patients is higher in Asian population compared to the other population (50-55% vs. < 20%). These mutations are mostly distributed in four exons (exon18 to exon21)2. In‑frame deletions of exon19 (44%; E746‑A750deletion) and L858R substitutions in exon21 (41%) are the most prevalent mutations associated with sensitivity to EGFR-TKIs. The point mutations in exon18 (G719C, G719S and G719A) and exon20 (V765A and T783A) are less frequent; 5% and 1%, respectively1.
Presence of the “classical” mutations in exon19 and 21 are the best predictive biomarker for the efficacy of EGFR-TKIs with superior response rate (RR) of 60-70%, progression‑free survival (PFS) of 9-18.9 months, and overall survival (OS) more than 2 years compared with conventional chemotherapy in patients with tumors harboring EGFR‑sensitive mutations making EGFR-TKI is the first-line treatment3. Currently, there are 3 generations of EGFR-TKIs approved in the market. The strategy of first-line treatment in EGFR-positive patients can be categorized into 2 strategies. The first one is treating by the single agent EGFR-TKIs. The first and second-generation EGFR-TKIs have the efficacy in term of PFS of 9-14.7 months in first-line treatment, but if starting with third generation EGFR-TKI, the PFS is longer (18.9 months)3-4. The ORR is similar either starting with 1st, 2nd, or 3rd generation EGFR-TKIs (60-70%). The acquired resistance could be occurred after 9-14 months of treatment by 1st and 2nd-generation EGFR-TKIs and the majority of resistance mechanism is T790M (50-60%) which is now we have the 3rd-generation EGFR-TKI for overcoming this resistance. Moreover, the other bypass tracts (MET amplification, BRAF, HER2 mutation etc.)5 could be the mechanism of resistance as well and we have the potential targeted drugs in the clinical studies which some of them will be approved in the near future. The mechanism of resistance if we start the 1st-line treatment with 3rd-generation EGFR-TKI is different from the previous one. Recently, exploratory data from FLAURA study was reported. They found no T790M detected in the patients whom had progressive disease after 1st-line treatment with 3rd-generation EGFR-TKI. The most common detected acquired resistance genes in the blood were C797S and MET amplification. The other mechanism included HER2 amplification, PIK3CA and RAS mutations. Furthermore, the 3rd-generation EGFR-TKI has the significant strong evidence of better in survival outcome and CNS response in patient whom had the CNS metastases disease6. The second strategy is starting 1st-line treatment with the combination therapy. The recent studies reported in ASCO2018 and ASCO2019 showed the longer PFS (16-19 months) in combination of 1st- generation EGFR-TKI and anti-angiogenesis agents and also longer PFS (16-20 months) in combination of 1st-generation EGFR-TKI with doublet platinum-based chemotherapy compared to single agent 1st-generation EGFR-TKI.7-9 Definitely, there were more adverse events for the combination treatment. The rate of occurring T790M as the acquired resistance and the CNS efficacy are the issues to concern for the combination treatment (Figure 1). The most proper sequence of the treatment in EGFR-positive NSCLC is needed to explore more in the clinical studies. It has pros and cons in each approach and it depends on several factors such as; the patients’ performance status, the location of tumor (CNS metastases?), types of EGFR mutations, acquired resistance, toxicities, treatment after progression, cost of treatment and the reimbursement issue in each country.
In summary, EGFR mutation is the crucial oncogenic-driven mutation in NSCLC with effective EGFR-TKI treatment making the patient has good quality of life (QOL) even though they have the advanced-stage disease. The journey of treatment in this group of patients is still underway of development and it is the good prototype for the other targeted drugs development in the clinical studies. I believe that there will be the other effective novel targeted treatments for NSCLC approved in the near future which would improve the long-term survival and QOL for patients.
References:
1. Salomon DS, et al. Crit Rev Oncol Hematol 1995
2. Lynch TJ, et al. N Engl J Med 2004
3. Reungwetwattana T, et al. Journal of Carcinogenesis 2013
4. Soria JC, et al. N Engl J Med 2018
5. Papadimitrakopoulou V, et al. ESMO Congress 2018
6. Reungwetwattana T, et al. J Clin Oncol. 2018
7. Furuya N, et al. ASCO Congress 2018
8. Nakamura A, et al. ASCO Congress 2018
9. Nakagawa K, et al. ASCO Congress 2019
Figure 1: The survival outcome of each approach for EGFR-positive NSCLC
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ES14.02 - First Line in ALK Translocated Patients (Now Available) (ID 3231)
15:15 - 16:45 | Presenting Author(s): Alice T. Shaw
- Abstract
- Presentation
Abstract
Chromosomal rearrangement of ALK defines a distinct subset of non-small cell lung cancer (NSCLC) with marked sensitivity to small molecule ALK tyrosine kinase inhibitors (TKIs). Currently, five ALK TKIs are approved as standard therapies for advanced ALK-positive NSCLC, including the first generation ALK/ROS1/MET inhibitor crizotinib, the second generation ALK inhibitors ceritinib, alectinib and brigatinib, and most recently the third generation ALK/ROS1 inhibitor lorlatinib. In three randomized phase 3 studies (J-ALEX, global ALEX, and ALESIA), alectinib has demonstrated superior efficacy compared to crizotinib, and has replaced crizotinib as the standard first-line therapy for advanced ALK-positive NSCLC. Recently, in a planned interim analysis of the ALTA-1L phase 3 study, brigatinib has also shown superior efficacy to crizotinib as first ALK TKI in advanced ALK-positive NSCLC. In this talk, we will review all the available first-line data with ALK TKIs, with a focus on next-generation ALK inhibitors. In addition to discussing second-generation ALK TKIs, we will also highlight available data with lorlatinib in the first-line setting. The phase 3 study of lorlatinib vs crizotinib as first-line therapy (CROWN) has completed accrual, with results expected within the next year. Finally, we will discuss the potential role of investigational combinations as first-line therapy in advanced ALK-positive NSCLC. These investigational strategies hold the promise of further extending front-line progression-free survival as well as overall survival for this molecular subgroup of patients.
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ES14.03 - First Line in ROS1 Translocated Patients (Now Available) (ID 3232)
15:15 - 16:45 | Presenting Author(s): Frances Shepherd
- Abstract
- Presentation
Abstract not provided
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ES14.04 - First Line for Rare Mutations (RET, BRAF, HER2) (Now Available) (ID 3233)
15:15 - 16:45 | Presenting Author(s): David Planchard
- Abstract
- Presentation
Abstract
Systemic therapy for non-small cell lung cancer (NSCLC) has undergone a dramatic paradigm shift over the past decade. In the recent years a number of other oncogenic drivers beyond EGFR, ALK, and ROS1 inhibition have emerged as novel molecular targets with potential therapeutic implications, including mutations in the genes BRAF, HER2, as well as RET rearrangements. A great number of clinical trials are currently underway, evaluating agents specifically designed to target these alterations. Here, we discuss both established and emerging targeted therapy approaches, as well as ongoing challenges for the treatment of NSCLC patients harboring these oncogenic alterations.
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ES14.05 - Patients Harbouring a Driven-Mutation: Pro and Patient's Perspective (Now Available) (ID 3234)
15:15 - 16:45 | Presenting Author(s): Karen L Reckamp
- Abstract
- Presentation
Abstract
Patients Harbouring a Mutation-Driven NSCLC—Pro and Patient Perspective
Karen L. Reckamp, MD, MS
City of Hope Comprehensive Cancer Center, Duarte, CA, USA
Genomic alterations in non-small cell lung cancer (NSCLC) define distinct subtypes with specific mechanisms leading to constitutive activity of a gene pathway, and tumor growth and metastasis. Targeted therapy for NSCLC with oncogenic driver mutations or alterations, usually with small molecule tyrosine kinase inhibitors (TKIs), has changed the paradigm for treatment of patients. New genetic alterations continue to be described with potential therapeutic interventions, and over 60% of patients with the adenocarcinoma subtype of NSCLC have a defined molecular alteration1. The perspective of the clinician and patient merges on the ideal that treatment for NSCLC should provide a long duration of cancer control (ideally tumor shrinkage) with limited side effects, and improvement in quality of life. Some aspects of treatment with targeted therapy may be more important to the treating physician, while patients may have a differing viewpoint during care. This will be explored.
From a clinician’s lens, the treatment for patients with NSCLC harbouring an alteration that can be treated with a targeted therapy involves an algorithm that includes the ideal sequencing of therapy. This requires determining the best front line therapy based on progression free survival (PFS) and overall survival while including the toxicity profile into the algorithm, and also assessing possible mechanism of resistance and options for subsequent therapy. A front line option should not be withheld based on second line options, but sequencing of therapy to increase survival and quality of life becomes an important part of the treatment decision (Table 1). This may be best exemplified in the case of EGFR mutant NSCLC, in which osimertinib demonstrated clear PFS benefit over erlotinib or gefitinib.2 In this case, mechanisms of resistance are still being elucidated and subsequent therapy becomes chemotherapy combinations. Recent studies have shown PFS benefit with first generation EGFR TKIs in combination with ramucirumab or chemotherapy, but were not directly compared to osimertinib. Furthermore, the toxicity with the combination therapy was also increased. Therefore, the choice of osimertinib as front line therapy is optimal for most patients. Another important aspect in the physician choice of front line therapy is brain penetration, which most TKI therapy is able to achieve, but some are better than others. Importantly, patients will not be treated with novel targeted therapies if they are not tested. Testing can include single gene testing by PCR and FISH, NGS testing and hotspot analysis either on blood or tissue. The utility of liquid biopsies to identify alterations in the metastatic front line setting has been shown,3 and detection has led to actionable therapy.4
Patients expect their physicians to be advocates for their therapy and their lives, and want a reason to hope. Most would like to avoid chemotherapy if possible in the course of treatment. They want the most current, and extensive testing done to determine the right therapy, but also encounter the economic impact of diagnosis and treatment of oncogene-driven NSCLC. Untangling the clinical trial data to provide the therapy most likely to prolong quality of life and survival is essential. Inadequate testing up front can lead to inappropriate treatments, and increased anxiety associated with additional tests and time required to find the right treatment. A NSCLC patient who is also a physician provides valuable insight into the patient perspective, “Everyone with lung cancer needs to have their cancer tissue tested for genetic mutations… That biopsy may lead to identifying mutations that can be successfully targeted. All therapies, whether conventional or targeted, provide bridges to keep you alive for the next therapy, to get to the next bridge. My ultimate goal is not necessarily to cure the disease, but to successfully manage the disease. Very much like the way HIV/AIDS and diabetic patients manage their disease for many, many years….to convert a death sentence to a chronic illness.”5
References
1. Kris MG, Johnson BE, Berry LD, et al. Using multiplexed assays of oncogenic drivers in lung cancers to select targeted drugs. JAMA : the journal of the American Medical Association 2014;311:1998-2006.
2. Soria JC, Ohe Y, Vansteenkiste J, et al. Osimertinib in Untreated EGFR-Mutated Advanced Non-Small-Cell Lung Cancer. N Engl J Med 2018;378:113-25.
3. Leighl NB, Page RD, Raymond VM, et al. Clinical Utility of Comprehensive Cell-free DNA Analysis to Identify Genomic Biomarkers in Patients with Newly Diagnosed Metastatic Non-small Cell Lung Cancer. Clinical cancer research : an official journal of the American Association for Cancer Research 2019.
4. Rothwell DG, Ayub M, Cook N, et al. Utility of ctDNA to support patient selection for early phase clinical trials: the TARGET study. Nature medicine 2019;25:738-43.
5. June 7, 2019
Table 1.
Oncogene
Mutation prevalence
Approved drugs
First-line drug of choice
Driver-oncogenes with approved agents
EGFR
Asian 30-40%/ Caucasian 10-20%
Erlotinib
Gefitinib
Afatinib
Osimertinib
Osimertinib
ALK
1-7%
Crizotinib
Ceritinib
Alectinib
Brigatinib
Lorlatinib
Alectinib
ROS1
1.7%
Crizotinib
Ceritinib
Crizotinib
BRAF
2%
Dabrafenib/trametinib
Dabrafenib/trametinib
NTRK
<1%
Larotrectinib
Larotrectinib
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EP1.16 - Treatment in the Real World - Support, Survivorship, Systems Research (ID 206)
- Event: WCLC 2019
- Type: E-Poster Viewing in the Exhibit Hall
- Track: Treatment in the Real World - Support, Survivorship, Systems Research
- Presentations: 1
- Now Available
- Moderators:
- Coordinates: 9/08/2019, 08:00 - 18:00, Exhibit Hall
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EP1.16-01 - A Spanish Initiative to Know the Unmet Needs of Women with Lung Cancer: "Circulos Program" (Now Available) (ID 1847)
08:00 - 18:00 | Author(s): Dolores Isla
- Abstract
Background
The personal and family impact of an oncological disease can only be adequately understood and managed from a biopsychosocial perspective. Lung cancer experience has a profound impact on the well-being of both patient and family caregiver and is largely influenced by communication within the family environment. Lung cancer impact can be especially significant when women are affected.
Method
The objective of this study was to develop an informative program for women with lung cancer, implementing the development of strategies in order to get a deepening knowledge of their perceived needs. Additionally, we aimed to define and design new useful resources that may help other women with lung cancer. A qualitative research allowed to collect data on the experiences in the circle of women and their families, and the identification of the needs and the coping resources used of the participants. The collection of these data was what led to the development of the tools used to develop the support strategies.
Result
A total of 10 women with lung cancer from Galicia (Spain) participated in 7 sessions. At the personal and psychological level in the women circle, needs were related to improve medical information they get from their physicians, share information and experiences with women in the same situation, more holistic-human care, and the need for more supporting groups. About the social and labor environment, they expressed concern about the social stigma associated with lung cancer, and the culpability for having smoked as well as the concern related to the interruption of working life. The family environment also expressed the need for emotional support and preparation for families and caregivers to be able to support the patient, the need to provide them with strategies to improve the situation, and the need to overcome initial isolation through working groups. Regarding resources, women´s circle was mainly focused on occupying time with new activities, humor and not stigmatizing the disease and the professionals who assist them.
Conclusion
“Círculos program”, even being a pilot program, show the benefits of a more humane approach to the treatment of lung cancer in women, with a better understanding of patients and families needs. More similar programs should be done in order to improve the quality of life of these patients and their transit through this disease.
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MA02 - Miscellaneous Topics in the Management of Early Stage Lung Cancer (ID 116)
- Event: WCLC 2019
- Type: Mini Oral Session
- Track: Treatment of Early Stage/Localized Disease
- Presentations: 1
- Now Available
- Moderators:Mireia Serra-Mitjans, Thomas A. D'Amico
- Coordinates: 9/08/2019, 10:30 - 12:00, Interlaken (1988)
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MA02.01 - Reccurrence Pattern After Adjuvant Customized Chemotherapy Based on BRCA Expression Level (SCAT Trial) (Now Available) (ID 2760)
10:30 - 12:00 | Author(s): Dolores Isla
- Abstract
- Presentation
Background
•Postop platinum-based CT improves outcomes in completely resected NSCLC with nodal involvement, (St II-IIIA). Customization is feasible in adjuvant setting (tissue availability) . Analysis of expressionin genes involved in DNA repair could be use to select CT regiment. •BRCA1 plays an important role in DNA repair pathways and functions as a differential regulator of response to cisplatin and antimicrotubuleagents. SCAT trial results found that for low BRCA1 levels subgroup Cis-Gemcitabine was superior to Cis-Docetaxel and in high BRCA1 levels subgroup Docetaxel single agent without platinum achieved similar survival to Cis-Doc. Analysis of recurrence pattern in different subgroups of the trials has been performed
Method
From Jun/2007 to May/2013 591 patients were screened and 500 p were included (108 in Control arm treated with Cisplatin-Docetaxel and 392 in Experimental arm treated with Cisplatin-Gemcitabine, Cisplatin-Docetaxel or Docetaxel alone according terciles BRCA1 expression level). With a cut-off September 30th 2018 and a median follow-up of 60 months, recurrence pattern are analysed in each arm and subgroup treatment and comparison are made for incidence of risk of recurrence, single/multiple recurrence, thoracic/extrathoracic and site of metastases (liver, bone, brain)
Result
Cumulative recurrence 232/456 evaluable patients (p) (50.8%). Recurrence were seen in 182/354 patients treated in experimental arm and in 50/102 p treated in the control arm (RR 1.04; 0.83-1.30) (p=0.672). Majority of recurrences 159/232 (68.5%) were single site recurrence. Intrathoracic recurrences in 121/232 (52%) while extrathoracic metastatic disease 111/232 (47.8%). No significant differences were seen for single/multiple, intra/extrathoracic recurrences between experimental and control arm. More frequent distant metastatic sites were: bone (42 p), brain (38 p) and liver (11 p) In the experimental group between different treatments no significant differences were found for the overall metastatic rate or for the single/multiple, intrathoracic/extrathoracic recurrences. For specific metastatic sites related to experimental treatment a significant reduction of risk of brain metastases were found in the experimental group with high level BRCA1 treated with Docetaxel single agent (p=0.0016)
Conclusion
For NSCLC resected patients with lymph node involvement (Stages II-IIIA) risk of recurrence remains high with cumulative rate > 50%. There were no differences in the Relative Risk (1.04) of recurrence when control and experimental arm are compared. Majority of recurrences were single site (68.5%) and intrathoracic (52%) but distant metastases developed in 47.8% os p. More frequent metastatic site was bone, followed by brain and liver. Brain metastases risk were significant lower for patients with low BRCA1 expression treated with single agent Docetaxel
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MA22 - Partnering with Patients to Understand Stigma, Disparities and Values Leading to Improved Lung Cancer Care (ID 154)
- Event: WCLC 2019
- Type: Mini Oral Session
- Track: Advocacy
- Presentations: 1
- Now Available
- Moderators:Diego Villalón, Christina Sit
- Coordinates: 9/09/2019, 15:45 - 17:15, Amsterdam (2011)
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MA22.05 - Assessment of Gender Differences in the Psychosocial and Economic Impact on Patients with Stage IV Non-Small Cell Lung Cancer (Now Available) (ID 718)
15:45 - 17:15 | Author(s): Dolores Isla
- Abstract
- Presentation
Background
Incidence of lung cancer in women is rising overtime reporting evident gender-based differences in epidemiology, biology, and treatment outcome. However, little is known about gender-differences regarding psychological, economic and social aspects. The objectives of this prospective study are to evaluate the psychosocial and economic impact of metastatic non-small cell lung cancer (NSCLC), according to gender. Additionally, to assess the emotional burden and the economic impact of the disease on the primary caregiver from a gender perspective
Method
Multicenter, prospective, observational, study of two cohorts of patients with metastatic NSCLC (male and female) in Oncology departments of 20 Spanish hospitals. The following measurement tools were used: the APGAR questionnaire (family functionality: adaptability, partnership, growth, affection, and resolve), the Relationship impact scale, the DUKE-UNC scale (perceived socio-affective support), the patient and the caregiver economic impact scale and the Zarit scale (caregiver burden). All questionnaires were performed at the first visit, repeated 4 months later and following the first and second disease progression.
Result
Of the 333 pts included, 104 were females and 229 male, of whom 63% and 97%, respectively, were smokers/ex-smokers (p=0.0001). More women than men (85% vs 70%) had adenocarcinomas . The median overall survival was longer in women but did not reach statistical significance [17.1 vs 11.0 months, HR 0.732 (95% CI 0.534 to 1.005), p=0.0524]. Most families considered themselves functional (high score in APGAR questionnaire) with no changes in their partner relationship and social support was evaluated as optimal for majority of patients. Around a quarter of interviewed patients said their economic situation was a little worse after the lung cancer diagnosis, without remarkable differences by gender. Statistically significant differences were found between both groups regarding the caregiver´s relationship to the patient (more parents were the caregiver in females than in males) (p <0.0001) and the caregiver’s employment situation (more employed caregivers in females) (p<0.0001). Most caregivers of both sexes considered that taking care of their relative did not pose a significant burden. No remarkable differences by gender were found between the different variables across the study.
Conclusion
This study provides a preliminary insight into gender-related characteristics in the management of advanced NSCLC and its impact on the emotional, social and economic burden of patients and their caregivers, and recall the high priority of researching in cancer from a gender perspective
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P2.14 - Targeted Therapy (ID 183)
- Event: WCLC 2019
- Type: Poster Viewing in the Exhibit Hall
- Track: Targeted Therapy
- Presentations: 1
- Moderators:
- Coordinates: 9/09/2019, 10:15 - 18:15, Exhibit Hall
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P2.14-63 - Cost Analysis of the Management of CNS Metastases in Patients with Advanced ALK+ NSCLC: Alectinib vs Crizotinib (ID 2174)
10:15 - 18:15 | Author(s): Dolores Isla
- Abstract
Background
The high prevalence of CNS metastases in ALK+ NSCLC leads to a significant clinical and economic burden. Alectinib demonstrated superior CNS activity and significantly delayed CNS progression versus crizotinib in untreated patients. Therefore, alectinib could reduce the brain metastasis-related healthcare resource utilization and costs.
The objective is to estimate the cost associated with the management of patients with advanced ALK+ NSCLC with and without CNS metastases, and to perform an analysis of the annual cost comparing patients treated with alectinib or crizotinib.
Method
Using the disaggregated consumption of resources provided by a panel of expert oncologists, the cost/year of the management of patients with ALK+ NSCLC with/without development of CNS metastases was estimated.
The cost of management (€,2018) included the quantification of medical visits, hospitalisations, diagnostic and laboratory tests, imaging techniques and radiotherapy procedures.
The unit costs of the resources were obtained from eSalud (Spanish database).
Using the 12-month cumulative incidence rate of CNS metastases in the ALEX trial for alectinib (9.4%) and crizotinib (41.4%), the annual cost of management with each therapy was estimated and compared.
An alternative analysis was performed considering the management of adverse events (AE) observed in the ALEX trial, with costs obtained from the literature.
Result
The cost/year of managing NSCLC was €6,173.42/patient without CNS metastases and €21,637.50/patient with CNS metastases.
In patients treated with alectinib, the average cost per patient was lower than in patients with crizotinib (-€4,948.51 patient/year) in the Spanish healthcare setting.
Considering the cost of AE, the average cost/year difference would be -€5,044.26/patient treated with alectinib vs crizotinib.
Conclusion
The delay in the appearance of CNS metastases associated with the treatment of alectinib vs crizotinib may result in a reduction in cost per year in the management of ALK+ NSCLC. Comprehensive approach of cost analysis should be adjusted to each disease characteristics.
