Clinical outcomes analysis of TP53-mutated advanced and metastatic biliary tract cancers.

4106 Background: Advanced biliary tract cancers (BTC) are lethal cancers with limited treatment options and short survival. Median progression-free survival (mPFS) in the ABC-02 trial was 8.0 months with gemcitabine-cisplatin (GC) and 5.0 m with gemcitabine alone in the front-line setting. The ABC-06 trial showed mPFS of 4.0 m with second-line FOLFOX. TP53 mutation is known to be associated with poor prognosis in other cancers, but its impact on survival in advanced or metastatic BTC has not been detailed. Methods: Mutational profiles were obtained from a retrospective database collected via an institutional DNA/RNA sequencing panel, FoundationOne, or Guardant360. Out of 149 patients with TP53 mutations in BTC, 90 had advanced or metastatic BTC treated at a single institution between 2015 and 2021. These patients were not candidates for surgery, radiation, or liver-directed therapy. Results: Intrahepatic, hilar, distal, and gallbladder cancer diagnoses were confirmed in 66, 11, 10, and 3 patients. Median age was 63, with a male:female ratio of 1:1. Poorly, moderately, and well-differentiated adenocarcinomas were found in 62, 20, and 1 (not available in 7 patients). The most common TP53 mutations were R175H (n = 5) and R248Q (n = 4). Common co-mutated genes included KRAS (n = 15), ARID1A (n = 15), FGFR2 fusion (n = 14), IDH1 (n = 13), BAP1 (n = 10), CDKN2A (n = 9), and HER2 amplification (n = 8). Microsatellite unstable (MSI-H) tumors were found in 3 patients. The median tumor mutational burden was 2.5/Mb. Patients received front-line GC (n = 54), GC-nab-paclitaxel (GAP, n = 14), FOLFIRINOX (n = 3), and GC with targeted or trial therapy (n = 11, e.g. trastuzumab). mPFS with front-line therapy was 5.0 m (n = 90); it was 4.7 m with GC and 5.1 m with GAP. Patients who had co-mutated IDH1 or FGFR2 fusion had longer mPFS (9.5 and 6.9 m, respectively) than those who did not (n = 63, 3.7 m, p < 0.05) from front-line chemotherapy. mPFS after second-line FOLFOX (n = 17) and FOLFIRI (n = 10) was 2.1 and 1.9 m, respectively, and mPFS after third-line FOLFOX/FOLFIRI was 1.8 m (n = 8). The median overall survival (OS) of patients with co-mutated FGFR2, IDH1, or neither was 34.5, 22.0, and 13.1 m, respectively (p < 0.05). TP53-mutated BTC with mutations other than FGFR2/IDH1 did not show statistically significant difference in PFS or OS. Conclusions: Patients with TP53-mutated advanced BTC have shorter PFS than those without TP53 mutation in front and further-line settings. The presence of co-mutated FGFR2 or IDH1 is associated with improved PFS with chemotherapy (not FGFR/IDH1 inhibitors) and longer OS. Other co-mutations do not appear to have a survival benefit. It is crucial for clinicians to take into account the worse prognosis with TP53 mutation before starting front-line therapy in patients with advanced BTC and consider early clinical trial options.

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Capecitabine plus Oxaliplatin as a Second-Line Therapy for Advanced Biliary Tract Cancers: A Multicenter, Open-Label, Phase II Trial

Journal of Cancer ◽

10.7150/jca.37610 ◽

2019 ◽

Vol 10 (25) ◽

pp. 6185-6190

Author(s):

Seung Tae Kim ◽

Sung Yong Oh ◽

Jeeyun Lee ◽

Jung Hun Kang ◽

Hyun Woo Lee ◽

...

Keyword(s):

Biliary Tract ◽

Phase Ii ◽

Phase Ii Trial ◽

Second Line ◽

Open Label ◽

Second Line Therapy ◽

Biliary Tract Cancers ◽

Line Therapy ◽

Open Label Phase

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FOLFIRI in advanced biliary tract cancers.

Journal of Clinical Oncology ◽

10.1200/jco.2019.37.4_suppl.451 ◽

2019 ◽

Vol 37 (4_suppl) ◽

pp. 451-451 ◽

Cited By ~ 2

Author(s):

Jonathan Mizrahi ◽

Valerie Gunchick ◽

Kabir Mody ◽

Lianchun Xiao ◽

Phani Keerthi Surapaneni ◽

...

Keyword(s):

Biliary Tract ◽

Group Performance ◽

Performance Status ◽

Treatment Options ◽

Eastern Cooperative Oncology Group ◽

Progression Free Survival ◽

Line Treatment ◽

Second Line ◽

Extrahepatic Cholangiocarcinoma ◽

Biliary Tract Cancers

451 Background: Gemcitabine plus platinum (GP) is the standard of care first-line treatment for advanced biliary tract cancers (BTC). There is no established second-line therapy, and retrospective reviews report progression-free survival (PFS) for second-line treatment to be < 3 months. 5-Fluorouracil plus irinotecan (FOLFIRI) is a commonly used regimen in patients (pts) with BTC who have progressed on GP, though there is a paucity of data regarding its efficacy in this population. Methods: We retrospectively evaluated pts with advanced BTC who were treated with FOLFIRI at MD Anderson, University of Michigan and Mayo Clinic in Jacksonville. Data were obtained on pt demographics, type of BTC, PFS, and overall survival (OS). Results: Ninety-eight pts were included of which 74 (76%) had metastatic disease at the time of treatment with FOLFIRI. The median age was 59 (range, 22 to 86) years. The number of pts with extrahepatic cholangiocarcinoma (CCA)/gall bladder (GB)/intrahepatic CCA were 10, 17, and 71. FOLFIRI was used as 1st, 2nd, 3rd or 4th – Nth lines in 8, 50, 36, and 4 pts, respectively. Of the 65 pts whose best responses were documented, 23 (35%) had stable disease and 7 (11%) had a partial response per RECIST v1.1. Median duration on FOLFIRI was 2.2 months. The median PFS and OS were 2.4 (95% CI 1.7 to 3.1) and 6.6 (95% CI 4.7 to 8.4) months, respectively. Median PFS for pts treated with FOLFIRI in 1st, 2nd, 3rd or 4th – Nth lines were 3.1, 2.5, 2.3 and 1.5 months, respectively. Eighteen pts received concurrent bevacizumab (13) or EGFR-targeted therapy (5) with FOLFIRI, and both of groups exhibited a median PFS of 2.7 months. Eastern Cooperative Oncology Group performance status (PS) of 0-1 was associated with improved OS (P = 0.006) compared to PS of 2-3. Conclusions: In this multi-institution retrospective review of 98 pts with BTC treated with FOLFIRI, efficacy of this regimen appears to be modest. While PFS and OS outcomes were similar to what has been previously reported, the 46% disease control rate in this group of predominantly pretreated pts is encouraging. Given the lack of other standard therapies, FOLFIRI may still have a role in this pt population, but these results emphasize the need for more effective treatment options for pts with advanced, pretreated BTC.

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The efficacy of anti-PD-1 combined with temozolomide in unresectable, advanced melanoma from one center.

Journal of Clinical Oncology ◽

10.1200/jco.2020.38.15_suppl.e22007 ◽

2020 ◽

Vol 38 (15_suppl) ◽

pp. e22007-e22007

Author(s):

Tu Hu ◽

Wei Sun ◽

Yu Xu ◽

Zhi-Guo Luo ◽

Yong Chen

Keyword(s):

Objective Response ◽

Progression Free Survival ◽

Advanced Melanoma ◽

Unknown Primary ◽

Second Line ◽

Front Line ◽

Second Line Therapy ◽

Free Survival ◽

Line Therapy ◽

Significant Difference

e22007 Background: Anti-PD1/PDL-1 immunotherapy has led to a new era of the unresectable, advanced melanoma treatment. However, there are still a significant part of patients suffer from primary or secondary drug resistance to immunotherapy. We sought to explore the efficacy and safety of anti-PD-1 plus Temozolomide in unresectable, advanced melanoma patients. Methods: Patients with unresectable, advanced melanoma were treated with anti-PD-1 plus Temozolomide, Temozolomide/DTIC based chemotherapy, or anti-PD-1 alone between 1 May, 2018 and 31 January, 2020. Data were retrospectively reviewed and statistically analyzed for best ORR and progression free survival, as well as toxicities. Results: Seventy-seven individuals were identified, including 37 (48.1%) with acral melanoma, 20 (26.0%) with cutaneous melanoma, 16 (20.8%) with mucosal melanoma and 4 (5.2%) with melanoma of unknown primary. Thirty-three (46.8%) patients had received postoperative adjuvant treatment before progression, and none of them had received anti-PD-1 treatment. The objective response rate of anti-PD-1 plus Temozolomide (n = 5, 41.7%) was higher than Temozolomide/DTIC (n = 1, 5%) or anti-PD-1 alone (n = 6, 20.7%) in the front-line therapy and second-line therapy (42.9%, 0%, 23.5%, respectively). Similar results were found in the third-line therapy. Although no significant difference was detected among these groups in the front-line therapy, the progression free survival of anti-PD-1 plus Temozolomide (median, 7 months) was higher than Temozolomide/DTIC (median, 2.5 months) (p = 0.009), while showing no significant difference with anti-PD-1 (median, 4.5 months) (p = 0.267) in the second-line therapy. The incidence of grade 3/4 toxicity was 8% (anti-PD-1 plus Temozolomide), 20.7% ( Temozolomide/DTIC) and 23.8% (anti-PD-1) respectively, mainly immunogenic pneumonia (0%, 0%, 10.3%) and hepatotoxicity (0%, 4.8%, 6.9%), and no significant difference was found among these groups. Conclusions: The efficacy of combination of anti-PD-1 and Temozolomide is better than Temozolomide/DTIC or anti-PD-1 alone in advanced melanoma and does not increase the toxicity. Therefore, Anti-PD-1 combined with Temozolomide may be used as front-line regimen in advanced melanoma.

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Survival of patients with metastatic HER2 positive gastro-oesophageal cancer treated with second-line chemotherapy plus trastuzumab or ramucirumab after progression on front-line chemotherapy plus trastuzumab

ESMO Open ◽

10.1136/esmoopen-2019-000539 ◽

2019 ◽

Vol 4 (4) ◽

pp. e000539 ◽

Cited By ~ 1

Author(s):

Christopher Nevala-Plagemann ◽

Justin Moser ◽

Glynn Weldon Gilcrease ◽

Ignacio Garrido-Laguna

Keyword(s):

Oesophageal Cancer ◽

Second Line ◽

Front Line ◽

First Line ◽

Current Standard ◽

Her2 Positive ◽

Line Therapy ◽

Significant Difference ◽

Line Chemotherapy

BackgroundThe role of continuing anti-HER2 therapy beyond progression on front-line therapy in patients with metastatic HER2 positive gastro-oesophageal cancer (GEC) is unclear. Continued chemotherapy plus trastuzumab (CT) has never been compared with the current standard second-line treatment, chemotherapy plus ramucirumab (CR).MethodsThe Flatiron Health electronic health record derived database, a nationwide database comprising patient-level structured and unstructured data, curated via technology-enabled abstraction, was reviewed for patients with metastatic HER2 positive GEC who received first-line CT, followed by second-line CT or CR. Survival from second-line therapy (SST) and time to next therapy or death (TTNTD) were compared using Kaplan-Meier curves and logrank analysis.Results133 patients with metastatic HER2 positive GEC who received first-line CT were identified. 32 received second-line CR and 101 received CT. Median SST for patients treated with CT versus CR was 10.2 months (IQR 5.1–20.8) and 6.8 months (IQR 2.4–20.2), respectively (p=0.29). Median TTNTD for second-line CT versus CR was 4.9 months (IQR 2.8–9.8) and 5.1 months (IQR 2.3–7.5), respectively (p=0.65). Patients who received second-line CT were more likely to receive a multiagent chemotherapy backbone (76% vs 3%, p≤0.001).ConclusionsThis analysis showed no significant difference in SST for patients treated with second-line CT versus CR. Further studies are needed to clarify the role of trastuzumab in the second line, especially in patients with confirmed retention of HER2 positivity following progression.

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Efficacy and Toxicity of Addition of Bevacizumab to Chemotherapy in Patients with Metastatic Colorectal Cancer

Combinatorial Chemistry & High Throughput Screening ◽

10.2174/1386207322666190119162352 ◽

2019 ◽

Vol 21 (10) ◽

pp. 718-724 ◽

Cited By ~ 2

Author(s):

Wen-Cong Ruan ◽

Yue-Ping Che ◽

Li Ding ◽

Hai-Feng Li

Keyword(s):

Colorectal Cancer ◽

Adverse Event ◽

Metastatic Colorectal Cancer ◽

Line Treatment ◽

Second Line ◽

First Line ◽

Second Line Therapy ◽

Clinical Prognosis ◽

Line Therapy ◽

Significant Difference

Background: Pre-treated patients with first-line treatment can be offered a second treatment with the aim of improving their poor clinical prognosis. The therapy of metastatic colorectal cancer (CRC) patients who did not respond to first-line therapy has limited treatment options. Recently, many studies have paid much attention to the efficacy of bevacizumab as an adjuvant treatment for metastatic colorectal cancer. Objectives: We aimed to evaluate the efficacy and toxicity of bevacizumab plus chemotherapy compared with bevacizumab-naive based chemotherapy as second-line treatment in people with metastatic CRC. Methods: Electronic databases were searched for eligible studies updated to March 2018. Randomized-controlled trials comparing addition of bevacizumab to chemotherapy without bevacizumab in MCRC patients were included, of which, the main interesting results were the efficacy and safety profiles of the addition of bevacizumab in patients with MCRC as second-line therapy. Result: Five trials were eligible in the meta-analysis. Patients who received the combined bevacizumab and chemotherapy treatment in MCRC as second-line therapy showed a longer overall survival (OS) (OR=0.80,95%CI=0.72-0.89, P<0.0001) and progression-free survival (PFS) (OR=0.69,95%CI=0.61-0.77, P<0.00001). In addition, there was no significant difference in objective response rate (ORR) (RR=1.36,95%CI=0.82-2.24, P=0.23) or severe adverse event (SAE) (RR=1.02,95%CI=0.88-1.19, P=0.78) between bevacizumab-based chemotherapy and bevacizumabnaive based chemotherapy. Conclusion: Our results suggest that the addition of bevacizumab to the chemotherapy therapy could be an efficient and safe treatment option for patients with metastatic colorectal cancer as second-line therapy and without increasing the risk of an adverse event.

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Relapse After Early-Stage, Favorable Hodgkin Lymphoma: Disease Characteristics and Outcomes With Conventional or High-Dose Chemotherapy

Journal of Clinical Oncology ◽

10.1200/jco.20.00947 ◽

2021 ◽

Vol 39 (2) ◽

pp. 107-115

Author(s):

Paul J. Bröckelmann ◽

Horst Müller ◽

Teresa Guhl ◽

Karolin Behringer ◽

Michael Fuchs ◽

...

Keyword(s):

Hodgkin Lymphoma ◽

Early Stage ◽

High Dose Chemotherapy ◽

Sensitivity Analyses ◽

High Dose ◽

Second Line ◽

Second Line Therapy ◽

Line Therapy ◽

Significant Difference ◽

First Diagnosis

PURPOSE We evaluated disease and treatment characteristics of patients with relapse after risk-adapted first-line treatment of early-stage, favorable, classic Hodgkin lymphoma (ES-HL). We compared second-line therapy with high-dose chemotherapy and autologous stem cell transplantation (ASCT) or conventional chemotherapy (CTx). METHODS We analyzed patients with relapse after ES-HL treated within the German Hodgkin Study Group HD10+HD13 trials. We compared, by Cox proportional hazards regression, progression-free survival (PFS) after relapse (second PFS) treated with either ASCT or CTx and performed sensitivity analyses with overall survival (OS) from relapse and Kaplan-Meier statistics. RESULTS A total of 174 patients’ disease relapsed after treatment in the HD10 (n = 53) and HD13 (n = 121) trials. Relapse mostly occurred > 12 months after first diagnosis, predominantly with stage I-II disease. Of 172 patients with known second-line therapy, 85 received CTx (49%); 70, ASCT (41%); 11, radiotherapy only (6%); and 4, palliative single agent therapies (2%). CTx was predominantly bleomycin, etoposide, doxorubicin cyclophosphamide, vincristine, procarbazine, and prednisone (BEACOPP [68%]), followed by the combination regimen of doxorubicin, bleomycin, vinblastine, and dacarbazine (19%), or other regimens (13%). Patients aged > 60 years at relapse had shorter second PFS (hazard ratio [HR], 3.0; P = .0029) and were mostly treated with CTx (n = 33 of 49; 67%) and rarely with ASCT (n = 8; 16%). After adjustment for age and a disadvantage of ASCT after the more historic HD10 trial, we did not observe a significant difference in the efficacy of CTx versus ASCT for second PFS (HR, 0.7; 95% CI, 0.3 to 1.6; P = .39). In patients in the HD13 trial who were aged ≤ 60 years, the 2-year, second PFS rate was 94.0% with CTx (95% CI, 85.7% to 100%) versus 83.3% with ASCT (95% CI, 71.8% to 94.8%). Additional sensitivity analyses including OS confirmed these observations. CONCLUSION After contemporary treatment of ES-HL, relapse mostly occurred > 12 months after first diagnosis. Polychemotherapy regimens such as BEACOPP are frequently administered and may constitute a reasonable treatment option for selected patients with relapse after ES-HL.

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1338. Analysis of Prescription Guideline Adherence in Pediatric Outpatient Pneumonia Treatment

Open Forum Infectious Diseases ◽

10.1093/ofid/ofaa439.1520 ◽

2020 ◽

Vol 7 (Supplement_1) ◽

pp. S680-S681

Author(s):

Carly Heck ◽

Judith Martin ◽

Marcia Kurs-Lasky

Keyword(s):

Drug Allergy ◽

Health Concern ◽

Second Line ◽

First Line ◽

Second Line Therapy ◽

First Line Therapy ◽

Line Therapy ◽

Comparison Results ◽

Significant Difference ◽

Recommended Therapy

Abstract Background Background: Antibiotic resistance is a major public health concern. A modifiable intervention is outpatient antibiotic stewardship. The goal of this study was to review the electronic health records (EHR) of children diagnosed with community acquired pneumonia (CAP) to compare patients who received non-guideline concordant therapy with those prescribed recommended therapy. Methods Methods: This was a retrospective chart review of 300 children (6 months to 6 years old) with an outpatient diagnosis of CAP between July 2017 and June 2019. 45 Children’s Hospital of Pittsburgh (CHP) and UPMC Children’s Community Pediatrics (CCP) practices were included. CHP practices are academic-based with trainees involved in visits, while CCP practices do not include trainees. First-line recommended therapy was defined as amoxicillin, second-line therapy as azithromycin or amoxicillin-clavulanate, and all other prescriptions were defined as other. Patients prescribed first-line therapy were compared to patients with second-line therapy or other. If first-line therapy was not prescribed, the EHR was manually reviewed for justification. If drug allergy was listed, the medication allergy and type of reaction were recorded. Results Results: In this study the minority of children (43%) were prescribed first-line therapy. This group was younger (57 vs. 63 months of age), more likely to be Non-white (80%), and seen at the CHP locations than those prescribed non-guideline concordant therapy. The average symptom duration was shorter, heart rate and respiratory rate were higher and the presence of fever was more common in the first-line therapy group. Justification for non-guideline therapy was most often reported as to provide coverage for atypical organisms. The most common drug allergy recorded was amoxicillin, and urticaria with unknown timing was the most common type of reaction. Demographics Comparison Results Justification for Second-line / Other Therapy and Drug Allergy Results Conclusion This project observed a high proportion of children being prescribed non-guideline concordant therapy for a diagnosis of CAP. Age, race, practice location, and severity of illness measures showed a statistically significant difference between groups. This study highlights the importance of education which reviews the current guidelines and the most likely pathogens for children with CAP. Disclosures All Authors: No reported disclosures

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Phase (Ph) 1b/2 evaluation of olaratumab in combination with gemcitabine and docetaxel in advanced soft tissue sarcoma (STS).

Journal of Clinical Oncology ◽

10.1200/jco.2021.39.15_suppl.11517 ◽

2021 ◽

Vol 39 (15_suppl) ◽

pp. 11517-11517

Author(s):

Steven Attia ◽

Victor Manuel Villalobos ◽

Nadia Hindi ◽

Brian Andrew Van Tine ◽

Andrew J. Wagner ◽

...

Keyword(s):

Systemic Therapy ◽

Objective Response ◽

Locally Advanced ◽

Primary Objective ◽

Clinical Activity ◽

Parameter Estimates ◽

Second Line ◽

Line Therapy ◽

Significant Difference ◽

Ecog Ps

11517 Background: Doxorubicin (doxo) remains standard first-line therapy for advanced STS. Doxo in combination with olaratumab (O) demonstrated superior clinical activity compared to doxo alone in a Ph 2 trial (NCT01185964), although this was not confirmed in the subsequent Ph 3 trial (NCT02451943). Gemcitabine (G) plus docetaxel (D) is a second line therapy for advanced STS. Here, we report a concurrent Ph 2 study that explored a second-line addition of O to G and D for advanced STS (ANNOUNCE 2 NCT02659020). Methods: Adult patients (pts) with unresectable locally advanced or metastatic STS, ≤ 2 prior lines of systemic therapy, and ECOG PS 0-1 were eligible. Pts were enrolled from 2 cohorts: O-naïve and O-pretreated. In both cohorts, pts were randomized 1:1 to either O, G plus D or placebo (PBO), G plus D. Pts received 21-day cycles of O (20 mg/ kg cycle 1 and 15 mg/kg other cycles, day (d) 1 and d8), G (900 mg/m2, d1 and d8) and D (75 mg/m2, d8). Pts continued treatment until progression, toxicity, or withdrawal. Randomization was stratified by histology (leiomyosarcoma [LMS] vs non-LMS), prior systemic therapy, ECOG PS, and prior pelvic radiation. The primary objective was overall survival (OS) in the O-naïve population using an alpha level of 0.20. Secondary endpoints included OS (O-pretreated) and other efficacy parameters, as well as safety and pharmacokinetics (PK). Results: 167 pts were enrolled in the O-naïve cohort and 89 pts in the O-pretreated cohort. Baseline patient characteristics were well balanced. OS for O-naïve pts was 16.8 vs 18.0 months (m) (hazard ratio [HR] = 0.95, 95% CI: 0.64-1.40; p = 0.78) for the investigational vs control arm, respectively. Other efficacy outcomes are presented in the table. Safety was manageable across treatment arms. PK parameter estimates for O were consistent with previous studies. Conclusions: There was no statistically significant difference in OS between the two arms in the O-naïve population. However, while not statistically significant, the combination of O, G and D demonstrated favorable OS in the O-pretreated cohort, and PFS and objective response rate (ORR) in both cohorts. For O-naïve pts, a clinically meaningful progression-free survival (PFS) improvement was observed. Further investigations in specific histological subtypes are ongoing. Clinical trial information: NCT02659020. [Table: see text]

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Determining the efficiency of the Imatinib mesylate and monitoring of relapse and emergence of IM resistance in Algerian adult patients with Chronic Myeloid Leukaemia

South Asian Journal of Experimental Biology ◽

10.38150/sajeb.8(3).p103-108 ◽

2019 ◽

Vol 8 (3) ◽

pp. 103-108

Author(s):

Amel Sebaa ◽

Mustapha Diaf ◽

Sakina Cherif Touil

Keyword(s):

Chronic Myeloid Leukaemia ◽

Myeloid Leukaemia ◽

Imatinib Mesylate ◽

Second Generation ◽

Adult Patients ◽

Second Line ◽

Second Line Therapy ◽

Molecular Responses ◽

Line Therapy ◽

Significant Difference

Imatinib mesylate (IM) shows remarkable clinical activity in patients with Chronic Myeloid Leukaemia (CML). Patients who fail to respond to IM or those who lose their response should be treated with second-generation tyrosine kinase inhibitors (TKIs). The aim of this study was to determine the efficiency of the Indian IM generic (Imatib*CIPLA), and to monitor relapse and emergence of IM resistance. Two hundred and seven adult patients from the Northwestern region of Algeria were diagnosed as CML in chronic phase (CP) and were treated with an Indian generic of IM at 400 mg/day. The IM 600 mg treatment and second-line therapy were prescribed after failure of treatment. Molecular Analysis was performed and BCR-ABL/ABL ratios were determined and standardised according to the international scale using 0.47 as conversion factor. Our findings showed a significant difference in major molecular response (MMR) for patients treated with IM 600 mg compared to IM 400 mg (51.7% vs. 37.6%, p<0.001). In the second line therapy group, there was a significant improvement of MR4.5 compared to the IM group (7.7% vs. 32.6%, p=0.039). Likewise, no significant relationship was found between the median duration of second-generation TKIs deep response and IM 400 mg/day regarding the MR4 (11 vs. 26.5 months, p=0.107) and MR4.5 (20 vs. 32.5 months, p=0.203). The Indian IM generic molecule (Imatib*CIPLA), has shown its efficiency in achieving major and deep molecular responses. Patients treated with the second-generation TKIs showed deep molecular responses with fewer relapses in a shorter median time than those treated with IM.

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