Systemic treatment of advanced colorectal cancer: FOLFOX or XELOX?

Schematy chemioterapii oparte na oksaliplatynie w połączeniu z fluoropirymidynami są jednym ze standardów postępowania w terapii I linii zaawansowanego raka jelita grubego. Kapecytabina jest doustną pochodną fluoropirymidyn wykazującą równą skuteczność w monoterapii raka jelita grubego co podawany dożylnie 5-fluorouracyl. Ostatnio opublikowano wyniki kilku randomizowanych badań klinicznych III fazy porównujących skuteczność oraz tolerancję leczenia schematów XELOX (kapecytabina + oksaliplatyna) i FOLFOX/FUOX/FUFOX (przedłużony wlew dożylny 5-fluorouracylu + oksaliplatyna) w terapii I linii zaawansowanego raka jelita grubego. Wyniki kilku badań wskazują na nieco niższą skuteczność schematu XELOX w porównaniu z FOLFOX, a wstępne dane z dwóch innych badań udowadniają, iż schematy XELOX i FOLFOX są porównywalne pod względem skuteczności. Po dodaniu bewacyzumabu skuteczność obu schematów jest nadal porównywalna, choć wydaje się, że bewacyzumab w większym stopniu zwiększa aktywność chemioterapii XELOX niż FOLFOX, a w jednym badaniu obserwacyjnym średnie przeżycia bez progresji choroby były nieznacznie dłuższe w grupie leczonej z zastosowaniem schematu XELOX + bewacyzumab. Toksyczność leczenia związana ze stosowaniem obu schematów nie różni się znamiennie. Na podstawie dostępnych danych wydaje się, iż schemat FOLFOX pozostaje standardem w leczeniu I linii zaawansowanego raka jelita grubego.Chemotherapy with oxaliplatin and fluoropirymidines is one of the standard regimens for treatment of advanced colorectal cancer in the first-line setting. Capecitabine is an oral fluoropirymidine showing equal efficacy in monotherapy of colorectal cancer as intravenous 5-fluorouracil. Recently, the results of few randomized phase III trials comparing the efficacy and tolerability of XELOX (capecitabine + oxaliplatin) vs. FOLFOX/FUOX/FUFOX (infusional 5-flurorouracil + oxaliplatin) regimens in the first-line treatment of advanced colorectal cancer have been published. The results of few studies indicate marginally inferior activity of XELOX, whereas preliminary data from other two studies prove that XELOX and FOLFOX have equal efficacy. After adding bevacizumab, the activity of the two regimens remains comparable, however it seems that bevacizumab increases the activity of XELOX regimen more compared to FOLFOX, and in one observational study progression free survival in XELOX + bevacizumab arm was slightly longer. Toxicity of these two regimens does not differ significantly. Based on available data, it seems that FOLFOX remains the standard treatment regimen for advanced colorectal cancer in the first-line setting

Giant, transformed dermatofibrosarcoma protuberans in female patient with newly diagnosed type 1 neurofibromatosis — a case report

Dermatofibrosarcoma protuberans (DFS) is a rare, cutaneous, locoregionally aggressive malignancy with a low risk of distant metastases. Neurofibromatosis type 1 (NF1, von Recklinghausen disease) is a genetical predisposition to the development of malignant tumors. The presented case describes atypical coincidence of DFS and NF1 in 30 year old female. The giant tumor was localized on the left side of the neck. It was non-radically excised. The pathological report described dermatofibrosarcoma protuberans progressing into epithelioid sclerosing fibrosarcoma. Adjuvant sequential chemotherapy and radiotherapy was planned. After 3 cycles of doxorubicin, the chest X-ray revealed pulmonary metastases; the radical therapy was stopped with no subsequent radiotherapy. Systemic treatment with ifosfamide was started. After 6 cycles the progression was shown. Considering the agressiveness of the disease and the patient’s excellent performance status, the next line of chemotherapy was started with doxorubicin and dacarbazine. According to our knowledge, there is only one report of coincidence of DFS and NF1, but without histological progression into more aggressive type of sarcoma. Onkol. Prak. Klin. 2010; 6, 3: 116–119Dermatofibrosarcoma protuberans (DFS) jest rzadkim nowotworem skóry o miejscowej złośliwości, z niewielkim ryzykiem wystąpienia przerzutów odległych. Nerwiakowłókniakowatość typu 1 (NF1, choroba von Recklinghausena) to genetycznie uwarunkowana skłonność do rozwoju nowotworów złośliwych. Zaprezentowane doniesienie opisuje nietypowe zachorowanie na DFS w przebiegu NF1 u 30-letniej pacjentki. Olbrzymi guz zlokalizowany był na szyi po stronie lewej. Guza zoperowano nieradykalnie. Histopatologicznie rozpoznano DFS z progresją w kierunku fibrosarcoma epithelioides sclerosans. Pacjentkę zakwalifikowano do uzupełniającej chemio-, a następnie radioterapii. Z powodu pojawienia się przerzutów do płuc w trakcie leczenia chemicznego (3 cykle doksorubicyny w monoterapii) odstąpiono od radioterapii, a dalszą chemioterapię ifosfamidem kontynuowano z założeniem paliatywnym. Po kolejnych 6 cyklach wystąpiła progresja choroby. Wobec agresywnego przebiegu choroby oraz bardzo dobrego stanu ogólnego chorej podjęto próbę chemioterapii kolejnego rzutu według schematu doksorubicyna z dakarbazyną. W piśmiennictwie odnaleziono jeden przypadek występowania DFS w przebiegu NF1, jednak bez histologicznej progresji w kierunku bardziej złośliwej formy mięsaka. Onkol. Prak. Klin. 2010; 6, 3: 116–11

Pilot testing and preliminary psychometric validation of the Polish translation of the EORTC INFO25 questionnaire : validation of the Polish version of INFO25-pilot study

The quality of information that oncological patients receive from health care professionals is an underestimated issue in Poland and Eastern European countries. There is lack of sufficient data on this subject. The European Organization for Research and Treatment of Cancer (EORTC) supplies a new tool for measuring the quality of information provided to cancer patients. The purpose of the study is the translation into Polish, pilot testing and preliminary validation of the EORTC information module (INFO25). Following the EORTC translation procedures, forward and back translations of the questionnaire were performed (English → Polish, Polish → English). The intermediate version of the INFO25 was pilot-tested together with the general questionnaire of quality of life (EORTC QLQ-C30). Reliability, validity and known-group comparison tests were performed. A total of 21 patients with different cancer diagnoses were recruited into the study (7 women and 14 men; mean age of 60,2 years, age range 25–73 years). Apart from filling out the INFO25, patients were interviewed about the difficulties with answering every questionnaire item. Patients' comments were analyzed and minor language changes were made to the initial translation. The internal consistency of the INFO25 showed a reliability of 0,78. The final version of the Polish translation of the INFO25 module was obtained and approved by the EORTC Quality of Life Department. It can now be used in clinical setting and for scientific purposes

Main influencing factors and health-related quality of life issues in patients with oesophago-gastric cancer : as measured by EORTC tools

AIM OF THE STUDY: To assess influencing factors and main health-related quality of life (HRQoL) issues in patients with cancers of the oesophago-gastric region using the European Organization for Research and Treatment of Cancer (EORTC) quality of life questionnaire Core 30 (QLQ-C30) and its oesophago-gastric module (QLQ-OG25). MATERIAL AND METHODS: Patients were qualified for this study based on the histological confirmation of oesophageal, oesophago-gastric or gastric cancers. Each patient filled out the Polish version of the EORTC QLQ-C30, the QLQ-OG25 module and a personal questionnaire. Patients were divided into groups based on gender, age, treatment intention, tumour localization, working status and level of education. RESULTS: Our study included 112 patients – 39 women (35%) and 73 men (mean age ± SD; 60.2 ±10.9). Thirty-five patients (31.3%) completed the questionnaires twice. Eighty-four (75%) patients had gastric cancer (GC), twenty-six (23.2%) oesophageal cancer (OC) and two (1.8%) cancer of the oesophago-gastric junction (OGJC). Eighty (71.4%) patients underwent surgical treatment prior to either chemo-, radio- or chemoradiotherapy. The Global Health Status scale of the QLQ-C30 inversely correlated with all the other QLQ-C30 and QLQ-OG25 symptom scales (r = –0.26 to –0.61; p < 0.05). CONCLUSIONS: The main HRQoL problems of Polish OC, OGJC and GC patients are fatigue, insomnia, anxiety, and appetite and weight loss. Older age, receiving palliative treatment, having gastric cancer, being on retirement and having lower education are factors associated with higher symptom scores (worse symptoms) and thus poorer HRQoL

Anthracycline-induced cardiotoxicity prevention with angiotensin-converting enzyme inhibitor ramipril in women with low-risk breast cancer : results of a prospective randomized study

Background: Anthracycline‑induced cardiotoxicity (AIC) remains the main long‑term irreversible side effect in malignancy survivors. Cardiotoxicity prevention is one of the most reasonable approaches. Aims: In this prospective randomized open‑label study, we aimed to verify whether ramipril protects from early‑onset AIC in women with breast cancer (BC). Methods: We analyzed data from 96 women (median age, 47 years) with BC after breast surgery, without significant cardiovascular diseases, who were eligible for adjuvant anthracyclines. They were randomized to a ramipril or control arm. Cardiotoxicity was estimated with repeat echocardiography and themeasurement of troponin I and N‑terminal fragment of the prohormone brain natriuretic peptide (NT‑proBNP) levels over 1‑year follow‑up. Anthracycline‑induced cardiotoxicity was defined as a decrease in left ventricular ejection fraction (LVEF), elevated biomarker levels, and/or occurrence of heart failure (HF) or cardiac death. Results: A decrease in LVEF above 10‑percent points occurred in 6.3% of ramipril patients and 18.5% ofcontrols (P = 0.15). No cases of HF, cardiac death, or LVEF decline below 50% were reported. The percentage of patients with elevated NT‑proBNP levels increased with time in controls (P = 0.003) and remained unchanged in the ramipril arm. At the end of follow‑up, an increase in NT‑proBNP levels was more common and decline was less common in the control than ramipril arm (P = 0.01). No significant differences in troponin levels were found between the study arms. Ramipril was well tolerated in normotensive women. Conclusions: In relatively young women with BC without serious comorbidities, who received anthracyclines, 1‑year treatment with ramipril exerts potentially protective effects on cardiotoxicity assessed with NT‑proBNP levels

Enhanced recovery (ERAS) protocol in patients undergoing laparoscopic total gastrectomy

INTRODUCTION: Laparoscopic technique combined with the ERAS (Enhanced Recovery after Surgery) protocol enables a shorter hospital stay and a lower complication rate. Although it has been widely used in many patients undergoing elective abdominal surgery, especially in patients with colorectal cancer, there are only a few papers describing laparoscopic total gastrectomy and the enhanced recovery protocol in patients with gastric cancer. Minimally invasive gastrectomy is still an uncommon procedure, mostly because of its difficulty. AIM: To present the preliminary results of treatment of patients with gastric neoplasms who underwent laparoscopic gastrectomy D2 with perioperative care according to ERAS principles. MATERIAL AND METHODS: Eleven patients (5 male and 6 female, age 52–77 years) underwent laparoscopic D2 gastrectomy with intracorporeal esophagojejunal anastomosis. In all patients the ERAS protocol was implemented. We analyzed operation time, complications and hospital stay. Additionally we focused on operative technique as well as the perioperative care protocol. RESULTS: The mean duration of the procedure was 245 min. There was 1 conversion due to unclear tumor infiltration. Mean hospital stay was 4.6 days. One postoperative complication (central venous catheter sepsis) was reported. Histological analysis confirmed the tentative diagnosis (R0 resection) in 10/11 patients. There were no readmissions. CONCLUSIONS: Laparoscopic gastrectomy is a valuable alternative to the classical approach and combined with the ERAS protocol can result in reduced hospital stay. However, due to the small group of patients it is difficult to adequately assess the incidence of early and late complications of the laparoscopic procedures; therefore further research is needed

Comparison of efficacy and safety of first-line palliative chemotherapy with EOX and mDCF regimens in patients with locally advanced inoperable or metastatic HER2-negative gastric or gastroesophageal junction adenocarcinoma : a randomized phase 3 trial

The aim of the study was to compare efficacy and safety of first-line palliative chemotherapy with (EOX) epirubicin/oxaliplatin/capecitabine and (mDCF) docetaxel/cisplatin/5FU/leucovorin regimens for untreated advanced HER2-negative gastric or gastroesophageal junction adenocarcinoma. Fifty-six patients were randomly assigned to mDCF (docetaxel 40 mg/m(2) day 1, leucovorin 400 mg/m(2) day 1, 5FU 400 mg/m(2) bolus day 1, 5FU 1000 mg/m(2)/d days 1 and 2, cisplatin 40 mg/m(2) day 3) or EOX (epirubicin 50 mg/m(2) day 1, oxaliplatin 130 mg/m(2) day 1, capecitabine 1250 mg/m(2)/d days 1–21). The primary endpoint was overall survival. The median overall survival was 9.5 months with EOX and 11.9 months with mDCF (p = 0.135), while median progression-free survival was 6.4 and 6.8 months, respectively (p = 0.440). Two-year survival rate was 22.2 % with mDCF compared to 5.2 % with EOX. Patients in the EOX arm had more frequent reductions in chemotherapy doses (34.5 vs. 3.7 %; p = 0.010) and delays in subsequent chemotherapy cycles (82.8 vs. 63.0 %; p = 0.171). There was no statistically significant difference in the rates of grade 3–4 adverse events (EOX 79.3 vs. mDCF 61.5 %; p = 0.234). As compared with the mDCF, the EOX regimen was associated with more frequent nausea (34.5 vs. 15.4 %), thromboembolic events (13.8 vs. 7.7 %), abdominal pain (13.8 vs. 7.7 %) and grades 3–4 neutropenia (72.4 vs. 50.0 %), but lower incidences of anemia (44.8 vs. 61.5 %), mucositis (6.9 vs. 15.4 %) and peripheral neuropathy (6.9 vs. 15.4 %). In conclusion, the mDCF regimen was associated with a statistically nonsignificant 2.4-month longer median overall survival without an increase in toxicity. This trial is registered at ClinicalTrials.gov, number NCT02445209