The Devil Is Not As Black As He Is Painted - 3-Year Experience of Treating Newly Diagnosed CML Patients with Imatinib Generics

Blood ◽  
2016 ◽  
Vol 128 (22) ◽  
pp. 5441-5441
Author(s):  
Vasily Shuvaev ◽  
Mikhail Fominykh ◽  
Vera Udaleva ◽  
Irina I Zotova ◽  
Regina Golovchenko ◽  
...  
Keyword(s):  
Adverse Events ◽  
Generic Drug ◽  
Patent Protection ◽  
Second Generation ◽  
Treatment Guidelines ◽  
Response Rates ◽  
Myelogenous Leukemia ◽  
Newly Diagnosed ◽  
Brand Name ◽  
Molecular Responses

Abstract Introduction. A generic drug is a pharmaceutical drug considered to be equivalent to a brand-name product. A generic drug has to contain the same active ingredients as those of the original formulation. Regulatory agencies used to require that generics be identical to their brand-name counterparts with regards to pharmacokinetic properties. In most cases, generic products are available after the patent protection given to a drug's original developer expires. In Russia, a patent protection lasts for a 10-year period from registration of the original drug. To this day, twelve Imatinib generics have been registered in Russia. Aim. To assess the safety and efficacy of Imatinib generics for treatment of newly diagnosed Chronic myelogenous leukemia patients that have been in our center since August 2012. Materials and methods. 30 newly diagnosed CML patients were started on generics. The drugs: 1) GenericPh 100 mg, in capsules (Ph-Syntez, Russia); 2) GenericG 100 mg, in tablets (Laboratorio TUTEUR S.A.C.I.F.I.A., Argentina); 3) GenericIm 100 mg, in tablets (Sandoz d.d. (Slovenia). Switching from one generic to another was done due to intolerance. We analyzed the range and frequencies of adverse events (AE), cumulative incidences of complete hematologic (CHR), major cytogenetic (MCyR), complete cytogenetic (CCyR), and early molecular responses (BCR-ABL<10% by IS), as well as the rate of BCR-ABL<1% by IS, major molecular (MMR) and molecular 4.0 log (MR4.0, BCR-ABL<0.01% by IS) responses at time-points according to the National CML diagnostic and treatment guidelines. The response rates were assessed only in regard to the generic treatment (with death, progression and switching to second-generation inhibitors as competing risks). Statistical analysis included descriptive statistics and cumulative incidence function. Results. Duration of the treatment with generics was 7-45 months, with a median of 13 months (GenericPh (27) + GenericG (2) + GenericIm (1)). No unexpected adverse events were observed during the Imatinib generics treatment. The generics tolerance did not differ from that of the original brand-name drug. Six patients were switched to second-generation tyrosine kinase inhibitors (TKI2) due to Imatinib intolerance. One patient progressed to blastic phase at 3 months after diagnosis. Three deaths were registered (1 - due to CML and 2 due to concomitant diseases). Overall survival rate was 90% and CML-related mortality - 3%. CHR at 3 months of the treatment was achieved in 93% of the patients. Cumulative response rates for cytogenetic and molecular responses are presented in Table 1. MR4.0 was registered in 23% of patients during overall treatment. Seven patients were switched to TKI2 due to insufficient efficacy of Imatinib. At the time of analysis 13 patients remained on Imatinib generics treatment: 12 patients with CCyR and 1 with PCyR, including 10 patients with MMR. Conclusion. Use of generics demands evaluation of its equivalency and control during its adoption into clinical practice. In terms of efficacy or tolerance no significant differences between the Imatinib generics studied and the original brand-name drug in newly diagnosed CML patients were found. Disclosures Shuvaev: Pfizer: Honoraria; BMS: Honoraria; Novartis pharma: Honoraria. Fominykh:BMS: Honoraria; Novartis Pharma: Honoraria.

Indication-Specific Generic Uptake of Imatinib Demonstrates the Impact of Skinny Labeling

2022 ◽  
Author(s):  
Bryan S. Walsh ◽  
Aaron S. Kesselheim ◽  
Ameet Sarpatwari ◽  
Benjamin N. Rome
Keyword(s):  
Patent Protection ◽  
Cross Sectional Study ◽  
Myelogenous Leukemia ◽  
Brand Name ◽  
Generic Competition ◽  
Cross Sectional ◽  
The Us ◽  
Lower Drug ◽  
The Impact ◽  
Brand Name Drugs

PURPOSE Generic competition can be delayed if brand-name manufacturers obtain additional patents on supplemental uses. The US Food and Drug Administration allows generic drug manufacturers to market versions with skinny labels that exclude patent-protected indications. This study assessed whether use of generic versions of imatinib varied between indications included and excluded from the skinny labels. METHODS In this cross-sectional study, we identified adult patients covered by commercial insurance or Medicare Advantage plans who initiated imatinib from February 2016 (first generic availability) to September 2020. Generic versions were introduced with skinny labels that included indications covering treatment of chronic myelogenous leukemia (CML) but excluded treatment of gastrointestinal stromal tumors (GISTs) because of remaining patent protections. Logistic regression was used to determine whether use of generic versus brand-name imatinib differed between patients with a diagnosis of CML or GIST, adjusting for demographics, insurance type, prior use of brand-name drugs, and calendar month. RESULTS Among 2,000 initiators, 934 (47%) had CML and 686 (34%) had GIST. Within 3 years after generics entered the market, more than 90% of initiators in both groups used generic imatinib. Initiation of generic imatinib was slightly lower among patients with GIST than among patients with CML (85% v 88%; adjusted odds ratio 0.56; 95% CI, 0.39 to 0.80; P ≤ .001). CONCLUSION Generic versions of imatinib were dispensed frequently for indications both included (CML) and excluded (GIST) from the skinny labeling, although patients with GIST were slightly less likely to receive a generic version. The skinny labeling pathway allowed generics to enter the market before patent protection for treating patients with GIST expired, facilitating lower drug prices.

Dasatinib Compared with Imatinib In Newly Diagnosed Chronic Myelogenous Leukemia In Chronic Phase (CML-CP):Results of Japanese Subset Analysis In DASISION Trial.

Blood ◽  
2010 ◽  
Vol 116 (21) ◽  
pp. 4484-4484
Author(s):  
Michinori Ogura ◽  
Hirohisa Nakamae ◽  
Shin Fujisawa ◽  
Kenichi Ishizawa ◽  
Masafumi Taniwaki ◽  
...  
Keyword(s):  
Adverse Events ◽  
Kinase Inhibitor ◽  
Chronic Phase ◽  
Japanese Patients ◽  
Myelogenous Leukemia ◽  
Molecular Response ◽  
Newly Diagnosed ◽  
Serious Adverse Events ◽  
Subset Analysis ◽  
To Receive

Abstract Abstract 4484 Background: Dasatinib is a highly potent BCR-ABL kinase inhibitor. The previous report from the global DASISION trial showed dasatinib 100 mg once daily resulted in significantly higher and faster rates of complete cytogenetic response (CCyR) and major molecular response (MMR) compared with imatinib; both treatment arms were well-tolerated (N Engl J Med. 2010;362:2260-70). The objective of this subset analysis was to assess the efficacy and safety of dasatinib compared with imatinib in the Japanese population. Methods: Forty-nine Japanese patients (total 519 pts) with newly diagnosed CML-CP were randomly assigned to receive dasatinib 100 mg QD or imatinib 400 mg QD. Confirmed CCyR (cCCyR; CCyR on 2 consecutive assessments at least 28 days apart) was the primary efficacy endpoint with MMR as an important secondary endpoint. The safety profiles were also evaluated. Results: Minimum follow-up time and median treatment duration were 12 months and 15 months, respectively. Twenty-six patients with median age 56 (range, 21–70) years were treated with dasatinib and 23 patients with median age 52 (range, 22–77) years were treated with imatinib. Overall 89% of patients receiving dasatinib and 83% of patients receiving imatinib continue to receive treatment. The cCCyR rate by 12 months (primary endpoint), CCyR rate by 12 months and MMR rate at any time in dasatinib arm were higher than those in imatinib for Japanese patients (96% vs 70%, 96% vs 78%, and 73% vs 48%, respectively). Grade 3/4 cytopenias in dasatinib arm and imatinib arm were as follows: anemia (8% vs 4%), neutropenia (27% vs 39%), and thrombocytopenia (8% vs 9%). Non-hematologic and drug-related adverse events occurring in ≥10% of patients are shown as Table. No deaths were reported in either group. Drug-related serious adverse events were rarely reported and all events were not severe (Grade 1–2, including vomiting, hypoxia and cardiomyopathy in dasatinib arm). Conclusion: Dasatinib showed higher rates of cCCyR and MMR compared with imatinib. Both treatments were well tolerated. Given the predictive value of 12 months cCCyR, dasatinib may improve long-term outcomes in Japanese patients with newly diagnosed CML-CP. Disclosures: Ueda: Bristol-Myers K.K.: Employment. Seriu:Bristol-Myers K.K.: Employment. Bradley-Garelik:Bristol-Myers Squibb: Employment. Zhu:Bristol-Myers Squibb: Employment.

scholarly journals Front-Line Therapy With Second-Generation Tyrosine Kinase Inhibitors in Patients With Early Chronic Phase Chronic Myeloid Leukemia: What Is the Optimal Response?

2011 ◽  
Vol 29 (32) ◽  
pp. 4260-4265 ◽  
Author(s):  
Elias Jabbour ◽  
Hagop M. Kantarjian ◽  
Susan O'Brien ◽  
Jianqin Shan ◽  
Alfonso Quintás-Cardama ◽  
...  
Keyword(s):  
Tyrosine Kinase ◽  
Tyrosine Kinase Inhibitors ◽  
Second Generation ◽  
Kinase Inhibitors ◽  
Chronic Phase ◽  
Cytogenetic Response ◽  
Myelogenous Leukemia ◽  
Newly Diagnosed ◽  
Front Line ◽  
Line Therapy

Purpose The response definitions proposed by the European LeukemiaNet (ELN) are defined on the basis of imatinib front-line therapy. It is unknown whether these definitions apply to patients treated with second-generation tyrosine kinase inhibitors (TKIs). Patients and Methods One hundred sixty-seven patients with newly diagnosed chronic myelogenous leukemia (CML) in chronic phase were treated with second-generation TKIs in phase II trials (nilotinib, 81; dasatinib, 86). Median follow-up was 33 months. Event-free survival (EFS) was measured from the start of treatment to the date of loss of complete hematologic response, loss of complete or major cytogenetic response, discontinuation of therapy for toxicity or lack of efficacy, progression to accelerated or blastic phases, or death at any time. Results Overall, 155 patients (93%) achieved complete cytogenetic response (CCyR), including 146 (87%) with major molecular response (MMR; complete in 46 patients [28%]). According to the ELN definitions, the rates of suboptimal response were 0%, 2%, 1%, and 12% at 3, 6, 12, and 18 months of therapy, respectively. There was no difference in EFS and CCyR duration between patients who achieved CCyR with and without MMR across all the landmark times of 3, 6, 12, and 18 months. Conclusion The use of second-generation TKIs as initial therapy in CML induces high rates of CCyR at early time points. The ELN definitions of response proposed for imatinib therapy are not applicable in this setting. We propose that achievement of CCyR and partial cytogenetic response at 3 months should be considered optimal and suboptimal responses, respectively. The achievement of MMR offered no advantage over CCyR in defining long-term outcome in patients with newly diagnosed CML treated with second-generation TKIs.

Efficacy of Nilotinib in Patients (Pts) with Newly Diagnosed, Previously Untreated Philadelphia Chromosome (Ph)-Positive Chronic Myelogenous Leukemia in Early Chronic Phase (CML-CP).

Blood ◽  
2009 ◽  
Vol 114 (22) ◽  
pp. 341-341 ◽  
Author(s):  
Jorge Cortes ◽  
Susan O'Brien ◽  
Dan Jones ◽  
Elias Jabbour ◽  
Marina Konopleva ◽  
...  
Keyword(s):  
Adverse Events ◽  
Research Funding ◽  
Philadelphia Chromosome ◽  
Myelogenous Leukemia ◽  
Hematologic Toxicity ◽  
Molecular Response ◽  
Newly Diagnosed ◽  
Blast Phase ◽  
Line Therapy ◽  
Grade 3

Abstract Abstract 341 Background: Nilotinib, an oral tyrosine kinase inhibitor with increased selectivity against Bcr-Abl and approximately 30-fold more potent than imatinib, is effective in CML after imatinib failure. We initiated a phase II study to evaluate the efficacy of nilotinib as 1st line therapy in pts with newly diagnosed CML-CP. Aims: To investigate the efficacy and safety of nilotinib as first-line therapy for pts with CML-CP. Methods: The primary objective was to estimate the proportion of pts attaining major molecular response (MMR) at 12 months (mo). Pts with untreated CML-CP within 6 mo from diagnosis were eligible and received nilotinib 400 mg twice daily. A cohort of patients with previously untreated CML in accelerated phase (AP) was also included. Results: Sixty-five pts (61 CP, 4 AP) have been treated for a median of 17 mo (range 1 to 43). The median age was 46 years (range 19 to 86). Among 48 pts who were not in CHR at the start, 47 (98%) achieved CHR (one discontinued after 2 weeks without adverse events). Among 51 pts followed for at least 3 mo, 50 (98%) achieved a complete cytogenetic response (CCyR). MMR has been achieved in 32 (63%) pts, including 12 (24%) with a complete molecular response. The rate of CCyR at different time points (intention-to-treat) for pts in CP compares favorably to that observed in historical controls treated with imatinib 400 mg or 800 mg daily: MMR was achieved by 55% at 12 mo and 53% at 24 mo (corresponding rates with imatinib 400 mg 34 and 55%, and with imatinib 800 mg 58% and 66%, respectively). Grade 3-4 hematologic toxicity (transient) included thrombocytopenia 11%, neutropenia 12%, and anemia 5%. Grade 3-4 non-hematologic adverse events (regardless of causality) included elevation of bilirubin in 8% and lipase in 6%, and non-neutropenic fever in 6%. 24 (37%) pts had transient treatment interruptions and 11 (17%) had dose reductions. The actual median dose is 800 mg daily. Ten pts have discontinued therapy: 4 pts for toxicity, 2 because of transformation to accelerated or blast phase, and 4 for other reasons. 24 mo EFS (event = loss of CHR, loss of MCyR, AP/BP, death, or off because of toxicity) is 90%. All patients are alive. Among pts in AP, 3 achieved CCyR (all of them sustained); one patient progressed to blast phase and died. Conclusion: Nilotinib 400 mg twice daily induces a CCyR in nearly all patients as early as 3 mo after the start of therapy and MMR in more than 50% at 12 months with a favorable toxicity profile. Disclosures: Cortes: BMS: Research Funding; Novartis: Research Funding; Wyeth: Research Funding. Off Label Use: Presentation will include use of nilotinib as initial therapy for CML, and indication for which nilotinib is not approved.. O'Brien:Novartis: Research Funding. Jones:Novartis: Research Funding, Speakers Bureau. Jabbour:Novartis: Speakers Bureau; BMS: Speakers Bureau. Borthakur:Novartis: Speakers Bureau. Kantarjian:Novartis: Research Funding; MGI Pharma (Eisai): Research Funding; Genzyme: Research Funding; BMS: Research Funding.

Impact of Dose Reductions and Interruptions Due to Adverse Events (AEs) on Efficacy in Newly Diagnosed Chronic Myeloid Leukemia in ChronicPhase (CML-CP) Patients (pts) Receiving Either Dasatinib (D) or Imatinib(IM): Analysis of the DASISION Trial

Blood ◽  
2011 ◽  
Vol 118 (21) ◽  
pp. 2768-2768 ◽  
Author(s):  
Elias Jabbour ◽  
Hagop M Kantarjian ◽  
Alfonso Quintas-Cardama ◽  
Francois Guilhot ◽  
Chao Zhu ◽  
...  
Keyword(s):  
Adverse Events ◽  
Dose Reduction ◽  
Research Funding ◽  
Response Rates ◽  
Similar Response ◽  
Medical Procedure ◽  
Newly Diagnosed ◽  
Employment Equity ◽  
Equity Ownership ◽  
Dose Reductions

Abstract Abstract 2768 Background: 24-month follow-up of pts with newly diagnosed CML-CP in the DASISION trial demonstrated both a high rate of complete cytogenetic response (CCyR) with dasatinib (D) and higher and faster rates of major molecular response (MMR) with D over imatinib (IM), supporting the use of D 100 mg once daily as a first-line treatment option for newly diagnosed CML-CP. Discontinuations due to adverse events (AEs) occurred in 7% with D and 5% with IM. Median dose intensity for D and IM were 99.5 mg/day and 400 mg/day, respectively (Kantarjian JCO 2011:29;Abs 6510). A retrospective analysis of pts from DASISION was performed to evaluate the impact of dose reductions and interruptions due to AEs on efficacy of D or IM in newly diagnosed CML-CP. Methods: Pts with newly diagnosed CML-CP received D 100 mg QD (N=258) or IM 400 mg QD (N=258). The primary endpoint was confirmed CCyR by 12 months. In DASISION, up to two dose reductions were permitted for AEs; dose reduction levels were 80 mg/50 mg for D and 300 mg/200 mg for IM. Dose interruptions were permitted for management of AEs. Upon resolution or improvement of AEs to ≤ Grade 1, pts could resume therapy at an appropriate dose based on initial severity of the AE. Efficacy was evaluated for pts with or without dose reductions and/or interruptions due to AEs at any time. Efficacy was also evaluated for pts with first dose interruption and/or reduction due to AEs within ≤6 or >6 months of their first dose who remained on treatment for at least 6 months, in order to reduce selection bias of pts with longer duration of therapy. Pts with dose reduction and/or interruption for reasons other than AEs (dosing error, medical procedure) were excluded from all analyses. Results: 134 D pts (52%) and 92 IM pts (36%) had dose reduction and/or interruption for AE management at the DASISION 24-month update. First dose reduction and/or interruption due to non-hematologic AEs occurred in 59 (23%) D and 40 (16%) IM pts and hematologic AEs in 75 (29%) D and 52 (20%) IM pts. Pts with dose reduction and/or interruption for reasons other than AE management were excluded, including 21 (8%) D pts and 19 (7%) IM pts. The median duration of first dose interruption due to AEs was approximately 2 weeks on both arms. CCyR and MMR rates with D were comparable whether pts did or did not have their dose reduced and/or interrupted at any time (Table). D pts who had dose reduction and/or interruption had generally higher rates of responses than IM pts overall and in those without an IM dose reduction and/or interruption. The timing of dose reduction and/or interruption appeared to have a potential impact as response rates were higher when dose reduction and/or interruption occurred >6 months after the first dose of either drug (Table). CCyR and MMR rates with D remained higher than with IM when dose reduction and/or interruption occurred ≤6 months from first dose. Similarly, both CCyR and MMR were higher for D than with IM if dose reduction and/or interruption occurred >6 months from the first dose. Conclusions: Results of this analysis suggest that CML-CP pts receiving dasatinib achieved similar response rates despite dose modification for the management of AEs. Data for pts with and without dose reduction and/or interruption due to AEs are consistent with DASISION 24-months results, showing higher rates of response with dasatinib than with imatinib. Disclosures: Kantarjian: Novartis: Consultancy, Research Funding; Bristol-Myers Squibb: Consultancy, Research Funding; Pfizer: Consultancy, Research Funding. Quintas-Cardama:Bristol-Myers Squibb: Honoraria. Guilhot:Novartis: Honoraria; Bristol-Myers Squib: Honoraria; Pfizer: Honoraria; Celgene: Honoraria. Zhu:Bristol-Myers Squibb: Employment. Hong:Bristol-Myers Squibb: Employment, Equity Ownership. Cain:Bristol-Myers Squibb: Employment, Equity Ownership. Cortes:Novartis: Consultancy, Research Funding; Bristol-Myers Squibb: Consultancy, Research Funding; Pfizer: Consultancy, Research Funding.

Cost of Myelosuppression with the Second Generation Tyrosine Kinase Inhibitors (TKIs) in Imatinib Resistant/Intolerant Chronic Myelogenous Leukemia (CML): An Economic Analysis Using Global Literature.

Blood ◽  
2007 ◽  
Vol 110 (11) ◽  
pp. 5177-5177 ◽  
Author(s):  
J. Stephens ◽  
K. Carpiuc ◽  
M. Botteman ◽  
W. Feng
Keyword(s):  
Adverse Events ◽  
Economic Analysis ◽  
Second Generation ◽  
Global Perspective ◽  
Myelogenous Leukemia ◽  
Short Term ◽  
Economic Implications ◽  
Imatinib Resistant ◽  
Grade 3 ◽  
The Cost

Abstract Background: New targeted therapies such as nilotinib and dasatinib show promise as options for patients with imatinib-resistant or -intolerant CML; however, concerns exist for these agents related to myelosuppression. The objective of this study was to compare the short-term cost of myelosuppression, from a global perspective, for chronic and accelerated phase CML patients treated with nilotinib and dasatinib. Methods: A global systematic literature review of the past 10 years was conducted using MEDLINE, Econlit and EMBASE to examine the potential costs of myelosuppression (specifically anemia, neutropenia and thrombocytopenia) in adult cancer patients, from the perspective of a health-care payer. An economic analysis was then developed using the ranges of cost data reported in literature, as well as the incidence rates of Grade 3/4 anemia, neutropenia and thrombocytopenia from nilotinib phase II clinical study reports and the dasatinib package insert for chronic and accelerated phase CML. All costs/currencies were converted to US dollars and inflated to 2006 using the country-specific medical inflation rates. Results: The cost of managing myelosuppression varied widely among countries based on patterns of inpatient compared to outpatient treatment, as well as the use of transfusions compared to recombinant growth factors. The reported cost ranges per AE episode were $124–$12,646 for anemia, $300–$27,440 for neutropenia and $239–$12,223 for thrombocytopenia from the following countries: UK, France, Germany, Italy, Spain, Netherlands, Finland, Switzerland, Belgium, Canada and the US. Expected 6-month costs per patient for Grade 3/4 myelosuppression adverse events with nilotinib and dasatinib are shown as ranges below: Chronic Phase Accelerated Phase Nilotinib $238–$5,550 $394–$9,064 Dasatinib $415–$9,929 $1,155–$23,674 Conclusions: Reflecting a broad range of countries, the expected short-term costs of Grade 3/4 myelosuppression with dasatinib may be 1.7 to 2.9 times higher than that associated with nilotinib. When considering the economic implications of different treatment options for imatinib-resistant or -intolerant CML, both the cost of the drug and the cost of managing adverse events should be taken into account. Future observational studies should be conducted to prospectively assess real-world adverse event costs with the second generation TKIs.

MARKETING AUTHORIZATION OF GENERIC DRUG: GLOBAL ISSUE AND CHALLENGES

2013 ◽  
Vol 1 (3) ◽  
pp. 1-6
Author(s):  
Pankaj Kashyap ◽  
Eshant Duggal ◽  
Parveen Budhwar ◽  
Jitendra Kumar Badjatya
Keyword(s):  
Generic Drug ◽  
Patent Protection ◽  
Drug Approval ◽  
Approval Process ◽  
Generic Medicines ◽  
Healthcare Provision ◽  
Pharmaceutical Markets ◽  
Global Issue ◽  
Drug Approval Process ◽  
High Level

Generic medicines are those whose patent protection has expired, and which may be produced by manufacturers otherthan the innovator company. Use of generic medicines has been increasing in recent years, primarily as a cost savingmeasure in healthcare provision. Generic medicines are typically 20 to 90% cheaper than originator equivalents. Theobjective is to provide a high-level description of what generic medicines are and how they differ, at a regulatory andlegislative level, from originator medicines. It describes the current and historical regulation of medicines in theworld’s two main pharmaceutical markets, in addition to the similarities, as well as the differences, between genericsand their originator equivalents including the reasons for the cost differences seen between originator and genericmedicines. This article refers to the general generic drug approval process in India, USA, and Japan. They havedifferent regulation and approval process. 

scholarly journals Effects of Cognitive Behavioral Therapy for Depression and Anxiety, Response Rates and Adverse Events in Patients with Locoregional Advanced Nasopharyngeal Carcinoma

2021 ◽  
Vol 20 ◽  
pp. 153473542110061
Author(s):  
Feng Liu ◽  
Sheng-nan Fu ◽  
Yan-zhu Chen ◽  
Ou-ying Yan ◽  
Fei Tong ◽  
...  
Keyword(s):  
Nasopharyngeal Carcinoma ◽  
Adverse Events ◽  
Cognitive Behavioral Therapy ◽  
Behavioral Therapy ◽  
Response Rates ◽  
Cognitive Behavioral ◽  
Toxic Effects ◽  
Depression And Anxiety ◽  
Small Effect Size ◽  
Anxiety Response

Purpose: This retrospective study investigated the effects of cognitive behavioral therapy (CBT) on depression, anxiety, response rates, and adverse events in patients with locoregional advanced nasopharyngeal carcinoma (NPC). Methods: A total of 269 patients with diagnosis of stage III-IVA NPC received either CBT plus chemoradiotherapy (CBT group, n = 136) or treatment as usual (TAU) plus chemoradiotherapy (TAU group, n = 133). Patients in the CBT group received a series of 6 CBT sessions for 6 weeks during concurrent chemoradiotherapy. Depression and anxiety were assessed using the Hospital Anxiety and Depression Scale (HADS) score at baseline, the completion of radiotherapy, and 6, 12, and 24 months after radiotherapy. Response rates and adverse events were also evaluated. Results: Patients in the CBT group showed significantly less depression and anxiety than patients in the TAU group after the completion of radiotherapy ( P < .05). Complete response rates were 99.3% (135/136) and 92.5% (123/133) in the CBT group and TAU group with a small effect size (Phi coefficient = .171), respectively ( P = .005). Compared with the TAU group, the CBT group showed a significantly lower incidence of acute adverse events and late toxic effects. Conclusions: The addition of CBT to chemoradiotherapy significantly reduced depressive and anxiety symptoms. CBT combined with chemoradiotherapy is associated with improved response rates, with reduced incidence of toxic effects in patients with locoregional advanced NPC. Based on this study, we registered a randomized controlled clinical trials to better define the role of CBT in patients with locoregional advanced NPC (Registration number: ChiCTR2000034701).

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