Are immune checkpoint inhibitors (ICI) a valid option for papillary renal cell carcinoma (pRCC)? A multicenter retrospective study.

582 Background: pRCC is the most common non-clear cell RCC (nccRCC) and represents up to 15% of RCC. Pivotal studies evaluating ICI mostly excluded nccRCC. Therefore the efficacy of ICI in pRCC remains to be demonstrated. Methods: We retrospectively investigated the activity and safety of PD-1/PD-L1 inhibitors (PD-1i) specifically in patients (pts) with metastatic pRCC from 15 centers in France and Belgium. Pts baseline characteristics, treatment outcome and safety were collected. Primary endpoint was time-to-treatment failure (TTF). Secondary endpoints included objective response rate (ORR), overall survival (OS) and treatment-related adverse events (TRAEs). Results: From 02/2016 to 09/2018, 50 pRCC pts treated with PD-1i were included. Median age was 63 years (range: 27-84), 36 (72%) were male. Histology included 14 (28%) type 1 pRCC, 30 (60%) type 2 pRCC, 6 (12%) unclassified pRCC. PD-1i was used in first line setting in 5 pts (10%), in second line in 29 pts (58%) and in third line or beyond in 16 pts (32%). IMDC risk group at PD-1i start was 22% good, 44% intermediate and 33% poor. ICI used were PD-1 inhibitors in 47 pts (94%) and PD-L1 inhibitors in 3 pts (6%). PD-1 in was used as monotherapy in 94% of pts. With a median follow up of 10.7 months (95% Confidence Interval (CI): 6.8-14.8), the median TTF was 3.7 months (95% CI: 3.1, 10.1). In type 1, the median TTF was 7.1 months (95% CI: 3.2-NA) and 3.2 months (95% CI: 2.9-NA) in type 2. Median treatment duration was 3.2 months (range: 0.4-24.5, IQR: 2.4-6.4). Among the 45 pts evaluable for ORR, best response was complete response/partial response in 8 pts (16%), stable disease in 13 pts (26%) and progressive disease in 24 pts (48%). ORR was 25% in type 1 pRCC and 15% in type 2 pRCC. Median OS was 17.6 months (95% CI 11.4- not reached). TRAEs of grade 3-4 were noted in 6 patients (12%) which led to treatment discontinuation, no grade 5 were observed. Conclusions: This retrospective study is the largest cohort of metastatic pRCC treated with PD-1i to date. PD-1i exhibit limited activity in this pRCC population, with better TTF and ORR in type 1 pRCC. Our findings underline the need for further prospective clinical trials evaluating ICI combinations in pts with pRCC.

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The impact of sequencing PD-1/PD-L1 inhibitors and stereotactic radiosurgery for patients with brain metastasis

Neuro-Oncology ◽

10.1093/neuonc/noz046 ◽

2019 ◽

Vol 21 (8) ◽

pp. 1060-1068 ◽

Cited By ~ 18

Author(s):

Rupesh Kotecha ◽

Joseph M Kim ◽

Jacob A Miller ◽

Aditya Juloori ◽

Samuel T Chao ◽

...

Keyword(s):

Stereotactic Radiosurgery ◽

Checkpoint Inhibitors ◽

Combined Modality Therapy ◽

Objective Response ◽

Complete Response ◽

Substantial Effect ◽

Durable Response ◽

Best Response ◽

Programmed Cell Death 1 ◽

The Impact

Abstract Background The response of brain metastases (BM) treated with stereotactic radiosurgery (SRS) and immune checkpoint inhibitors (ICIs; programmed cell death 1 and its ligand) is of significant interest. Methods Patients were divided into cohorts based on ICI sequencing around SRS. The primary outcome was best objective response (BOR) that was lesion specific. Secondary outcomes included overall objective response (OOR), response durability, radiation necrosis (RN), and overall survival (OS). Results One hundred fifty patients underwent SRS to 1003 BM and received ICI. Five hundred sixty-four lesions (56%) treated with concurrent ICI (±5 half-lives) demonstrated superior BOR, OOR, and response durability compared with lesions treated with SRS and delayed ICI. Responses were best in those treated with immediate (±1 half-life) ICI (BOR: −100 vs −57%, P < 0.001; complete response: 50 vs 32%; 12-month durable response: 94 vs 71%, P < 0.001). Lesions pre-exposed to ICI and treated with SRS had poorer BOR (−45%) compared with ICI naive lesions (−63%, P < 0.001); best response was observed in ICI naive lesions receiving SRS and immediate ICI (−100%, P < 0.001). The 12-month cumulative incidence of RN with immediate ICI was 3.2% (95% CI: 1.3–5.0%). First radiographic follow-up and best intracranial response were significantly associated with longer OS; steroids were associated with inferior response rates and poorer OS (median 10 vs 25 mo, P = 0.002). Conclusions Sequencing of ICI around SRS is associated with overall response, best response, and response durability, with the most substantial effect in ICI naive BM undergoing immediate combined modality therapy. First intracranial response for patients treated with immediate ICI and SRS may be prognostic for OS, whereas steroids are detrimental.

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Outcomes of patients (pts) with metastatic clear-cell renal cell carcinoma (mCCRCC) treated with second-line (2L) vascular endothelial growth factor receptor tyrosine kinase inhibitors (VEGFR-TKI) after first-line (1L) immune checkpoint inhibitors (ICI).

Journal of Clinical Oncology ◽

10.1200/jco.2018.36.6_suppl.682 ◽

2018 ◽

Vol 36 (6_suppl) ◽

pp. 682-682 ◽

Cited By ~ 8

Author(s):

Amishi Yogesh Shah ◽

Emily Lemke ◽

Jianjun Gao ◽

Anuradha Chandramohan ◽

Matthew T. Campbell ◽

...

Keyword(s):

Retrospective Study ◽

Kinase Inhibitors ◽

Checkpoint Inhibitors ◽

Objective Response ◽

Growth Factor Receptor ◽

Progression Free Survival ◽

Cell Renal Cell Carcinoma ◽

Impaired Wound Healing ◽

Kaplan Meier ◽

Best Response

682 Background: Little data exists on objective response rates (ORR), progression-free survival (PFS), and safety of 2L VEGFR-TKI after 1L ICI therapy in pts with mCCRCC. Methods: This is a retrospective study of pts with mCCRCC who received 2L VEGFR-TKI after progressive disease (PD) with 1L ICI. Tumor response was assessed by a blinded radiologist using RECIST 1.1. Descriptive statistics, the Fisher’s test, and Kaplan-Meier method were used. Results: We report on 43 pts who were treated at MDACC from 2015 till present. Median age at mCCRCC diagnosis was 59 years (range: 43-72). 33 pts had lung mets, 20 had LN mets, 14 had bone mets, and 3 had liver mets. As 1L therapy, 20 pts received nivolumab + ipilimumab, 14 received nivolumab + bevacizumab, and 9 received nivolumab. Median time on ICI therapy was 29.4 weeks. All pts had resolution of Grade 3/4 AEs from ICI and PD before initiation of VEGFR-TKI. One patient (2%) had CR, 17 pts (40%) had PR, and 25 pts (58%) had SD, leading to 100% disease control rate (DCR) as best response to 2L VEGFR-TKI. Median PFS was 10.0 months (95% CI: 7.4, NA). Estimated 1-yr overall survival (OS) was 87.5% (95% CI: 74.6 - 100). Seven pts (16%) discontinued VEGFR-TKI therapy because of AEs: Gr 3 transaminitis (3 on pazopanib), Gr 3 hand-foot skin reaction (1 on axitinib), impaired wound healing (1 on axitinib), and Gr 3 pancreatitis (1 on pazopanib, 1 on axitinib). Conclusions: In this retrospective study, we observed a 42% ORR, a 10-month median PFS, and a 100% DCR in pts with mCCRCC who received VEGFR-TKI after PD with ICI. These results inform the design of trials with 2L VEGFR-TKI after failure of ICI therapy. [Table: see text]

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Tailored immunotherapy approach with nivolumab in advanced transitional cell carcinoma (TITAN-TCC).

Journal of Clinical Oncology ◽

10.1200/jco.2021.39.6_suppl.446 ◽

2021 ◽

Vol 39 (6_suppl) ◽

pp. 446-446

Author(s):

Marc-Oliver Grimm ◽

Bernd Schmitz-Dräger ◽

Uwe Zimmermann ◽

Barbara Grün ◽

Gustavo Bruno Baretton ◽

...

Keyword(s):

Immune Checkpoint ◽

Response Rate ◽

Checkpoint Inhibitors ◽

Objective Response ◽

Transitional Cell ◽

Added Value ◽

Phase Iii ◽

First Line ◽

Third Line

446 Background: Several PD-1 immune-checkpoint inhibitors including Nivolumab (Nivo) are approved in urothelial cancer. Recently, in the front line setting, improved activity of combined PD-L1 and CTLA4 immune-checkpoint inhibition has been reported and a phase III trial with Nivolumab + Ipilimumab (Nivo+Ipi) is ongoing. Here we report a response-based tailored approach starting treatment with Nivo monotherapy using Nivo+Ipi as immunotherapeutic “boost”. Methods: Between July 2017 and April 2019 86 patients were enrolled and treated according to protocol version 3 (cohort 1). Patients started with Nivo 240 mg Q2W induction. After 4 dosings and tumor assessment at week 8 (i) responders (PR/CR) to Nivo monotherapy continued with maintenance while (ii) patients with stable (SD) or progressive disease (PD) received 2 cycles Nivo3+Ipi1 followed by another 2 cycles Nivo1+Ipi3 if not responding. Median follow-up is 8.7 months. The primary endpoint is confirmed investigator-assessed objective response rate (ORR) per RECIST1.1. Secondary endpoints include activity of Nivo monotherapy at week 8, remission rate with Nivo+Ipi “boosts”, safety, overall survival and quality of life. Results: Of the patients 42, 39 and 5 were first, second and third line, respectively. Median age was 67 years (range 45-84), 61 patients (71 %) were male and 25 female. ORR with Nivo monotherapy at first assessment (week 8) was 29 % and 23 % in first and second/third line, respectively. Of the patients 41 received Nivo+Ipi “boosts” after week 8 while 12 received later “boosts”. Best overall response (BOR) rate with Nivo induction ± Nivo+Ipi “boosts” was 48 % and 27 % in first and second/third line, respectively. In first line 7/17 (41 %) patients receiving Nivo+Ipi after week 8 had an improved response compared to 2/24 (8.3 %) in second/third line. Of the patients who continued with Nivo maintenance after week 8 and received later “boosts” 2/12 (17 %) had a PR and 2/12 (17 %) improved to SD. Treatment-related AEs will be presented. Conclusions: TITAN–TCC explores a response-driven use of Nivo+Ipi as an immunotherapeutic “boost”. In first line, this significantly improved ORR compared to the expected response rate of Nivo monotherapy, providing further evidence to the added value of Ipi in combination with Nivo. Further follow-up is ongoing to characterize duration and depth of response. Clinical trial information: NCT03219775 . Research Sponsor: Bristol-Myers Squibb[Table: see text]

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Efficacy of Chemotherapy or Chemo-Anti-PD-1 Combination after Unsatisfactory Response of Anti-PD-1 Therapy for Relapsed and Refractory Hodgkin Lymphoma: A Retrospective Series from Lysa Centers

Blood ◽

10.1182/blood.v130.suppl_1.652.652 ◽

2017 ◽

Vol 130 (Suppl_1) ◽

pp. 652-652

Author(s):

Cédric Rossi ◽

Julia Gilhodes ◽

Marie Maerevoet ◽

Charles Herbaux ◽

Pauline Brice ◽

...

Keyword(s):

Clinical Trials ◽

Hodgkin Lymphoma ◽

Research Funding ◽

Checkpoint Inhibitors ◽

Objective Response ◽

Complete Response ◽

High Rate ◽

High Dose ◽

Group 2 ◽

Group 1

Abstract Introduction: Hodgkin lymphoma (HL) pts who relapse after high-dose therapy (HDT) and autologous stem cell transplantation (ASCT) and brentuximab vedotin (BV) therapy have a poor outcome. For these relapsed and refractory (R/R) HL pts, anti-PD-1 therapy gives a high rate of objective responses. However, the rate of complete response (CR) remains modest and in the updated results of anti-PD-1 therapy clinical trials, about 50% of pts are still without progressive disease after one year of treatment. As anti-PD-1 therapy modifies the anticancer immune response, we hypothesize that anti-PD-1 therapy may increase sensitivity to chemotherapy (CT) given after anti-PD-1 therapy (sequential strategy) or in combination with anti-PD-1 therapy after an unsatisfactory response to immunotherapy (concomitant strategy). We retrospectively analyzed these two clinical situations in 30 R/R HL pts from LYSA centers treated with anti-PD-1 therapy. Methods: We included R/R HL pts from 14 LYSA centers who received anti-PD-1 therapy in the context of clinical trials (N=4) or an authorization for temporary use (ATU) from the French medical drug agency (N=26). Before the anti-PD-1 therapy, pts had received a median of six (range, 2-14) lines of therapy, 69% had HDT+ASCT, 14% had allograft and 93% had been treated with BV. We considered two groups of pts: i. 19 pts (63%) in whom the anti-PD-1 therapy was stopped at the introduction of CT (Group 1); ii. 11 pts (37%) with an unsatisfactory response to anti-PD-1 therapy in whom a combination of CT with immunotherapy was initiated to optimize the response (Group 2). The quality of the response after the introduction of CT was evaluated retrospectively by each treating physicians according to Cheson 2007 or 2014 criteria. We also determined whether new CT treatments after and in combination with anti-PD-1 therapy led to unexpected toxicities and whether new treatment schedules made pts eligible for allograft. Results: At the start of anti-PD-1, the median age of pts was 37 years old (range, 20-75), 24% had Ann Arbor III/IV stages, 34% had B symptoms and 21% had a performance status (PS) of 2-3. Patients received a median of 10 infusions (range, 2-52) of anti-PD-1 therapy with nivolumab (N=26, 87%) or pembrolizumab (N=4, 13%). The best responses achieved during anti-PD-1 therapy were a complete response (CR) for 5 patients, a partial response (PR) for 17 pts, stable disease (SD) for 2 pts and progression for 6 pts. In group 1, 17 pts were in progression, one pt in PR, and another pt in SD at the end of anti-PD-1 therapy alone. In group 1, after anti-PD-1 therapy, the pts were treated with vinblastine (N=3), gemcitabine (N=2) or bendamustine alone (N=3) or in combination with BV (N=4), GVD (N=1), ICE (N=1), DHAP (N=1), escalated BEACOPP (N=1), vinorelbine (N=1), vepeside (N=1) and caelyx (N=1). In group 2, before the combination, the response status was progression for 7 pts and PR for 4 pts. In group 2, to optimize the response to anti-PD-1, pts received vinblastine (N=7), gemcitabine (N=2) and BV (N=2). In the 28 evaluable pts, 11/18 (61%) in group 1 and 9/10 (90%) in group 2 showed an improved response after chemotherapy alone or combination with anti-PD-1 therapy respectively. In group 1, there were 6 CR (32%), 5 PR (26%), 1 SD (5%) and 6 PD (32%) (Figure 1B). In group 2, there were 5 CR (45%), 5 PR (45%) and 1 SD (10%) (Figure 1A). Of note, among the ten pts treated with vinblastine, 4 were in CR, 3 in RP, 1 in SD and 2 in progression. No unexpected toxicity was observed during the CT. Four pts had an allograft after the sequential CT (N=3) and concomitant CT strategy (N=1). Three pts were in CR 274, 279 and 480 days after the allograft and the fourth has not yet been evaluated. Allografts are now scheduled for 6 pts. With a median follow-up of 9.1 months (95%CI, 6.1-14) following the initiation of chemotherapy (alone or combined) the median PFS and OS were 8.4 and 14.6 months, respectively. Conclusions: Our retrospective study showed that pts with an unsatisfactory response or PD with anti-PD-1 therapy had a new objective response with CT alone (61%) or CT in combination with anti-PD-1 therapy (90%). This response could make some pts eligible for allograft. Prospective clinical trials are needed to confirm the synergistic effect of CT with anti-PD-1 therapy and to determine which CT provides the best results in combination with these checkpoint inhibitors. Figure 1 Figure 1. Disclosures Ysebaert: Janssen: Consultancy, Research Funding, Speakers Bureau. Ghesquières: Celgene and Mundipharma: Consultancy, Honoraria; Roche: Research Funding.

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Investigate the efficacy of immunotherapy for treatment of pancreatic adenocarcinoma (PDAC) with mismatch repair deficiency (dMMR).

Journal of Clinical Oncology ◽

10.1200/jco.2021.39.3_suppl.415 ◽

2021 ◽

Vol 39 (3_suppl) ◽

pp. 415-415

Author(s):

Arish Noor ◽

Luis E. Aguirre ◽

Kirsten Blue ◽

Trenton Avriett ◽

Estrella M. Carballido ◽

...

Keyword(s):

Pancreatic Adenocarcinoma ◽

Metastatic Disease ◽

Checkpoint Inhibitors ◽

Objective Response ◽

Locally Advanced ◽

Progression Free Survival ◽

Complete Response ◽

Median Number ◽

Cancer Center ◽

Duration Of Response

415 Background: Immune checkpoint inhibitors (ICI) have been approved in solid tumors with dMMR. However, only limited data are available for PDAC with dMMR given the rarity of dMMR in PDAC. We evaluated efficacy of ICIs in PDAC with dMMR. Methods: Retrospective clinical and pathologic data were collected for patients (pts) with pancreatic adenocarcinoma from May 2017 to June 2020 at Moffitt cancer center. Results: We identified 10 pts with dMMR PDAC. The median age was 64.5 years (range: 42-86) and 4 pts were male. 4 pts had resectable disease, 3 had locally advanced and 3 had metastatic disease at initial diagnosis. MSH6 deficiency (def) was found in 2 cases, PMS2 def in 2, MLH/PMS2 def in 5, and MSH2/MSH6 in 1. 7 pts were treated with ICIs. 3 pts had locally advanced and 4 had metastatic disease when they started ICIs. 5 received Pembrolizumab (pem), 1 received ipilimumab/ nivolumab (ipi/nivo), and 1 received pem then ipi/nivo after progressive disease (PD) on pem. The median number of prior lines of chemotherapy was 1 (range 0-2). 6 pts were evaluable, and 1 had rapid disease progression after 1 dose of pem. Among 6 evaluable pts, 3 had an objective response (1: complete response and 2: partial response), and 2 had stable disease (SD). Median progression-free survival was 8.2 mo, and median overall survival was not reached with median follow-up (FU) of 6.8 mo. The median duration of response was not reached with a median FU of 22.6 mo. The pt with CR remained disease-free for up to 22 months. The pt whose treatment was switched to ipi/nivo after PD on pem achieved SD > 4mo on ipi/nivo. While on immunotherapy, one patient with ipi/nivo developed immunotherapy associated rash requiring systemic steroids, and another on pem developed hypothyroidism requiring levothyroxine. Conclusions: This series suggest ICIs can provide durable clinical efficacy in pts with dMMR PDAC.

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A phase I trial evaluating NBTXR3 activated by radiotherapy in combination with nivolumab or pembrolizumab in patients with advanced cancers.

Journal of Clinical Oncology ◽

10.1200/jco.2021.39.15_suppl.2590 ◽

2021 ◽

Vol 39 (15_suppl) ◽

pp. 2590-2590

Author(s):

Colette Shen ◽

Jessica M. Frakes ◽

Jiaxin Niu ◽

Ari Rosenberg ◽

Jared Weiss ◽

...

Keyword(s):

Phase I ◽

Phase I Trial ◽

Tumor Regression ◽

Checkpoint Inhibitors ◽

Objective Response ◽

Kidney Injury ◽

Complete Response ◽

Intratumoral Injection ◽

Primary Objective ◽

Open Label

2590 Background: Immune checkpoint inhibitors (ICIs) targeting PD-1 are an effective treatment for a variety of cancers. However, the majority of patients (pts) exhibit resistance to ICIs. Overcoming this resistance represents a major challenge in immuno-oncology. Emerging evidence suggests radiation therapy (RT) produces an immunomodulatory effect that may act synergistically with ICIs. However, RT dose and ultimate efficacy are limited by toxicity to surrounding healthy tissues. NBTXR3, a novel radioenhancer administered by direct intratumoral injection (ITI), is designed at the nanoscale to increase RT dose deposit within tumor cells and subsequent tumor cell killing, without increasing toxicity to surrounding healthy tissue. Preclinical data suggest NBTXR3/RT can trigger a local and systemic anti-tumor immune response and overcome anti-PD-1 resistance. NBTXR3/RT combined with anti-PD-1 may prime the immune system to increase the proportion of ICI responders, or convert ICI non-responders to responders. Methods: This is a multicenter, open-label, phase I trial [NCT03589339] to evaluate NBTXR3/RT/anti-PD-1 in 3 cohorts: (1) Locoregional recurrent or recurrent and metastatic head and neck squamous cell carcinoma (HNSCC) amenable to HN re-irradiation, and metastases from any primary cancer eligible for anti-PD-1 (nivolumab or pembrolizumab) treatment specifically localized in the lung (2) or liver (3), respectively. Stereotactic body RT (SBRT) is delivered at tumor-site selective doses per standard practice. The primary objective is NBTXR3/RT/anti-PD-1 recommended phase 2 dose in each cohort. Secondary objectives are anti-tumor response (objective response rate), safety and feasibility of NBTXR3 injection. Results: Nine pts have been treated: 3 HNSCC, 4 lung, 2 liver. 7/9 pts were anti-PD-1 non-responders. Overall tumor regression was observed in 8/9 pts. NBTXR3/RT/anti-PD-1 resulted in tumor regression in 6/7 pts who had progressed on prior anti-PD-1. A complete response in the injected lymph node lasting over 1 year was observed in 1 anti-PD-1 naïve pt. 2 SAEs related to anti-PD-1 and possibly related to NBTXR3 (G5 pneumonitis, G4 hyperglycemia) were observed in 1 anti-PD-1 naïve HNSCC pt and considered DLTs. This pt also experienced 2 other SAEs related to anti-PD-1 (G4 diabetic ketoacidosis, G4 acute kidney injury). SBRT-related safety profile was as expected. Updated results will be presented. Conclusions: Data from this first-in-human phase I trial evaluating NBTXR3/RT/anti-PD-1 in pts with advanced cancers, show NBTXR3 ITI is feasible and well-tolerated. NBTXR3/RT/anti-PD-1 demonstrated promising signs of efficacy. Of particular interest, NBTXR3/RT can overcome ICI resistance in pts having progressed on prior anti-PD-1, supporting further development of NBTXR3 in combination with anti-PD-1 as well as other ICIs. Clinical trial information: NCT03589339.

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Efficacy of weekly paclitaxel-bevacizumab combination in advanced nonsquamous non-small cell lung cancer (NSCLC): AVATAX, a retrospective multicentric study.

Journal of Clinical Oncology ◽

10.1200/jco.2021.39.15_suppl.e21086 ◽

2021 ◽

Vol 39 (15_suppl) ◽

pp. e21086-e21086

Author(s):

Geoffroy Bilger ◽

Anne-Claire Toffart ◽

Marie Darasson ◽

Michaël Duruisseaux ◽

Lucie Ulmer ◽

...

Keyword(s):

Performance Status ◽

Objective Response ◽

Progression Free Survival ◽

Line Treatment ◽

Second Line ◽

Multicentric Study ◽

Significant Difference ◽

Third Line ◽

And Performance ◽

Line Setting

e21086 Background: With the growing role of immunotherapy (ICI) as first-line setting for advanced NSCLC, strategies must be redefined after failure. The combination paclitaxel-bevacizumab showed in the ULTIMATE trial a significant superiority versus docetaxel as second or third-line treatment. Limited restropective studies has demonstrated unexpected efficacy of chemotherapy after prior progression on ICI. This combination could be use as salvage treatment following ICI. Methods: This multi-centric retrospective study identifies patients treated with the combination paclitaxel-bevacizumab in metastatic non-squamous NSCLC as second-line therapy or beyond. Main objectives were to describe safety and efficacy of this combination, with a special attention to the sub-group treated just after ICI. Results: From January 2010 to February 2020, 314 patients started the paclitaxel-bevacizumab combination : 55% male, with a median age of 60 years, 27% with a performance status ≥2, 45% with brain metastases. A majority of patients were treated in second (20%) and third-line (39%), and 28% were treated just after ICI failure (88/314). Objective response rate (ORR) was 40% and disease control rate was 77 %. Median progression-free survival (PFS) and overall survival (OS) were 5,7 months [IQ,3,2–9,6] and 10,8 months [IQ,5,3–19,6] respectively. All grades adverse events concerned 82% of patients, including 53% asthenia and 39% neurotoxicity, and 25% of patients continued a monotherapy alone due to toxicity. Median PFS for patients treated after ICI failure (ICI+) was significantly superior compare to those not previously treated with ICI (ICI-) : 7,0 months [IQ,4,2–11,0] vs 5,2 months [IQ,2,9–8,8] p (log-rank) = 0,01. There was not statistically significant difference in term of OS between this two groups. In multivariate analysis, factors associated with superior PFS were previous ICI treatment (ICI+) and performance status. Conclusions: This study confirms an acceptable toxicity profile associated with interesting efficacy of the combination paclitaxel-bevacizumab as second-line treatment or beyond for non–squamous NSCLC patients, particularly after progression with ICI.

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Retrospective analysis of prescriptions in the management of lepra reactions: Results of a single center study from tertiary hospital in Maharashtra

Asian Journal of Pharmaceutical and Clinical Research ◽

10.22159/ajpcr.2017.v10i5.17346 ◽

2017 ◽

Vol 10 (5) ◽

pp. 191

Author(s):

Madhuri Kulkarni ◽

Anant Patil ◽

Siddharth Aathawale

Keyword(s):

Retrospective Study ◽

Antimicrobial Agent ◽

Retrospective Analysis ◽

Tertiary Hospital ◽

Single Center ◽

Single Center Study ◽

Multibacillary Leprosy ◽

Center Study

Objective: To examine pattern of lepra reaction andmedicines used in the treatment of lepra reactions in a tertiary hospital. Material methods: In this retrospective study, prescriptions of patients treated for the lepra reactions were reviewed to find out prevalence of type 1 and type 2 reactions and medicines used in the treatment of lepra reactions. Results:A total of66 patients (male 59.1%; female 40.9%) with mean age of 36.6 (+13.1) years were included in the study. Multibacillary leprosy was present in 93.7% patients. A total of 39 (60%) patients had type 2 reaction whereas 26 (40%) had type 1 reaction. Mean number of medicines per patients was 7.5. Prednisolone was used in 62 (93.9%) patients with mean duration of 33.32 (+33.2) days whereas chloroquine was used in 52 (78.8%) patients for 36.6 (+27.9) days. Thalidomide was used in 25 (37.9%) patients. Analgesic and anti-inflammatory and anti-acidity drugs were used in 63 (95.4%) patients each whereas paracetamol was given to 41 (62.1%) patients. Antihistamine, antimicrobial agent and vitamins were given to 27 (40.9%), 27 (40.9%) and 35 (53.0%) patients respectively. Conclusion:Lepra 2 reaction is more common than lepra 1 reaction. Prednisolone and chloroquine are the two most commonly used medicines in the treatment of lepra reaction. Similarly, thalidomide, older drug has emerged as common treatment for lepra reaction.

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