Our retrospective analysis compared the effectiveness of conventional antracycline-containing protocols (A+) and docetaxel/epirubicine (TE) as primary systemic chemotherapies (PSCT) for inflammatory breast cancer (IBC). Seventy IBC patients received either A + (n = 48) or TE (n = 22) as PSCT. The objective clinical response and clinical benefit rate of treated patients were 54.3% (A+: 54,2% vs. TE: 54,5%; p = 0,28) and 92.8% (A+: 91,7% vs. TE: 95,5%; p = 0,57), respectively. The clinical complete response rate (cCR) was 23.2% (A+: 27,1% vs. TE:4,5%; χ (2) = 4,79; p = 0,03) with 7.14% (A+: 10,4% vs. TE:0%; χ (2) = 2,47; p = 0,12) of pathological complete responses (pCR). The median progression free (PFS)/local progression free (LPFS)/overall survival (OS) was 2.0/5.4/4.0 years, respectively. Patients achieving cCR had a tendency for better survival parameters than patients with less than cCR. Response rates or survival data were not statistically different in the two chemotherapy (CT) treatment groups. The survival was not influenced by the number of CT cycles in either protocols. In this set of patients, the clinical efficacy of the two alternative primary systemic chemotherapies (A + and TE) is equivalent in the treatment of inflammatory breast cancer (IBC), despite of the significant difference in favour of A + noticed in CRs. Six cycles of CT could be enough for patients achieving CR, however sequential pre- and/or postoperative CT with non cross-resistant drugs should be considered for non-responders.
Randomized trials in advanced biliary tract cancer (BTC) did not show benefit of cetuximab addition over chemotherapy. This is probably due to the lack of predictive biomarkers. The aim of this study was to explore possible predictive factors. Between 2009 and 2014, 57 patients were treated in 3-week cycles with cetuximab (250 mg/m/week, loading dose: 400 mg/m), gemcitabine (1000 mg/m on day 1 and 8), and capecitabine (1300 mg/m/day on days 1-14). The objective response rate (ORR), progression-free (PFS) and overall survival (OS) and the adverse events (AEs) were evaluated. An exploratory analysis was performed to find possible predictive factors on clinicopathological characteristics, routine laboratory parameters and early AEs, which occurred within 2 months from the beginning of treatment. The ORR was 21%. The median PFS and OS were 34 (95% CI: 24-40) and 54 (43-67) weeks, respectively. The most frequent AEs were skin toxicities. In univariate analysis performance status, previous stent implantation, thrombocyte count at the start of therapy, early neutropenia and skin rash statistically significantly influenced the ORR, PFS and/or OS. In multivariate Cox regression analysis only normal thrombocyte count at treatment start and early acneiform rash were independent markers of longer survival. In patients showing early skin rash compared to the others the median PFS was 39 vs. 13 weeks and the median OS was 67 vs. 26 weeks, respectively. It is suggested that early skin rash can be used as a biomarker to select patients who would benefit from the treatment with cetuximab plus chemotherapy.
Background: Among the presently available cytotoxic drugs, paclitaxel, in combination with doxorubicin and carboplatin, come under the highly active therapy for metastatic breast cancer. Between the two brands of paclitaxel (Intaxel, which is marketed by Fresenius Kabi and Taxol, the original paclitaxel which is manufactured by BMS) the similarity has not been evaluated in clinical trial settings till date. This prospective, controlled, randomized, multicentre, open-label phase IV study was planned to compare the safety and efficacy of Intaxel with Taxol, when they were used in combination with carboplatin or doxorubicin, as a second line treatment for metastatic breast cancer. Methods:Fourty nine eligible patients were randomized to receive Intaxel or Taxol with either doxorubicin or carboplatin. The patients who had received a prior anthracycline based chemotherapy were randomized to the paclitaxel/carboplatin arm. The patients were evaluated in three phases i.e. at baseline, during the treatment and at follow up for the tumour response, the time period till the disease progression and the toxicity. The time till the disease progression was assessed by the KaplanMeier method. The continuous and categorical variables were assessed by using the ANOVA test and Fisher's exact test, respectively.Results: After 3 cycles, an objective response rate of 55.56% (CR = 3, PR = 7) was noted in the Intaxel group and that of 59.09% (CR = 1, PR = 12) was noted in the Taxol group. After 6 cycles, an objective response rate of 50% was noted in both the groups. No significant difference was observed in the response rate of the two groups after 3 cycles (p > 0.05) and at the end of the treatment (p > 0.05). The patients who received Intaxel had a lower incidence of thrombocytopaenia (p = 0.0146) and neurosensory loss (p = 0.008) as compared to those who received Taxol. Conclusion:The results of this study demonstrated that the safety and efficacy of Intaxel and Taxol are equivalent when they are used in combination with other cytotoxic agents as the second line of treatment for metastatic stage IV breast cancer.
BackgroundThymomas and thymic carcinomas (TC) are intrathoracic malignancies that, although rare, represent the most common anterior mediastinal tumors in adults (comprising approximately 0.2-1.5% of all malignancies).1 Recent accumulating evidence on immune checkpoint pathways suggests that immunotherapy might be a promising therapeutic option for refractory TCs.2 We herein report two cases of a pembrolizumab-treated TC patient.MethodsImmunotherapy is accessible through individual permission for the treatment of TC in Hungary. We retrospectively collected data of two TC patients treated with pembrolizumab in one institute.ResultsThe first patient was a 66-year-old woman. Squamous cell TC was diagnosed in her left parasternal region. She was a former smoker, had no history of autoimmune disorders, and had no associated symptoms at the time of diagnosis. She underwent open thymectomy. The histology proved type C (WHO classification) TC with a pathological TNM of T1aN0 and microscopic-positive margins. Consequently, the patient received 60 Gy of postoperative radiotherapy. Nine months after the surgery local recurrence and multiple hepatic metastases appeared. Six cycles of chemotherapy (ADOC regimen) were introduced as first-line systemic therapy which resulted in stable disease (SD) for 8 months. Pembrolizumab was administered as second-line treatment (200 mg every 3 weeks) for 6 cycles. The best result was SD. Due to progression, third-line docetaxel treatment was initiated. Shortly after, ptosis and diplopia developed. Myasthenia gravis was diagnosed, and third-line chemotherapy was judged ineffective. The second patient was a 63-year-old man. He was diagnosed with unresectable TC and treated with chemotherapy (ADOC regimen) up-front. After six cycles the tumor regressed, and surgery was performed with R2 result. Postoperatively, the patient was given six cycles of chemotherapy (cisplatin/etoposide) and radiotherapy. Six months later local progression was detected and pembrolizumab was commenced. Eight cycles of pembrolizumab produced SD as best response. No immune-related adverse effects (irAEs) were detected. After progression Sunitinib therapy was started. In both cases, additional immunohistochemistry investigations were performed.ConclusionsIn the literature, there is no phase 3 trial on immune-checkpoint inhibitor (ICI) therapy of TC. Phase 2 trials reported promising results with pembrolizumab.3 4 However, there are conflicting results with other ICIs.5 Before starting, it is important to rule out autoimmune disorders to evade serious, even life-threatening immune-complications. The high likelihood of irAEs in TC also underpin the importance of predictive biomarkers. Further studies are required to evaluate the efficacy and safety of immunotherapy in TC.AcknowledgementsThe authors thank the multidisciplinary clinical teams involved in the treatment and management of the patient.ReferencesBushan K, Sharma S, Verma H. A review of thymic tumors. Indian Journal of Surgical Oncology 2013;4(2):112–116. https://doi.org/10.1007/s13193-013-0214-2Isshiki T, Isobe K, Tochigi N, et al. Successful use of pembrolizumab to treat refractory thymic carcinoma with high PD-L1 expression. Case Rep Oncol2018;11(3):688–692. Published 2018 Oct 31. doi:10.1159/000493187Giaccone G, Kim C, Thompson J, McGuire C, Kallakury B, Chahine JJ, et al. Pembrolizumab in patients with thymic carcinoma: a single-arm, single-centre, phase 2 study. Lancet Oncol 2018;19:247–255.Cho J, Kim HS, Ku BM, Choi YL, Cristescu R, Han J, et al. Pembrolizumab for patients with refractory or relapsed thymic epithelial tumor: an open-label phase II trial. J Clin Oncol 2019;37(JCO2017773184):2162–2170.Katsuya Y, Horinouchi H, Seto T, Umemura S, Hosomi Y, Satouchi M, et al. Single-arm, multicentre, phase II trial of nivolumab for unresectable or recurrent thymic carcinoma: PRIMER study. Eur J Cancer 2019;113:78e86.
In recent years some serologic parameters emerged as potential prognostic factors. The neutrophil-to-lymphocyte ratio (NLR) has the most evidence; however, other serologic factors were also reported. The only established systemic treatment in triple-negative breast cancer (TNBC) is chemotherapy which is preoperatively applied more widely. For these patients few data are available on which serologic markers would be the best predictor for disease-free (DFS) and overall survival (OS). Data of 137 TNBC patients treated (2005-2016) with neoadjuvant chemotherapy at our center were analyzed. Beyond pathological factors, white blood cell (WBC), neutrophil (NE), lymphocyte (LY) and platelet (PL) counts, neutrophil-to-lymphocyte ratio (NLR), platelet-to-lymphocyte ratio (PLR), systemic immune-inflammation index (SII) were investigated. In univariate analysis, most parameters (NE1, LY1, NLR1, PLR1, SII1) measured at baseline and before the third cycle (NE3, LY3, etc.) of chemotherapy showed significant association with survival. After the exclusion of correlated variables, in multivariate analysis NLR1, Ki67 and pathological stage were independent predictors of DFS and OS. In an exploratory analysis new markers were found: dichotomization by NLR1xNLR3 and PL1/(PL3)2 resulted in significantly different DFS of patients with low and high NLR1, respectively. A high PL3xLY3 level was an exclusive marker of relapse after pathological complete remission.
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