Objective: to compare the efficacy and toxicity of aflibercept and bevacizumab in combination with fOLfIRI in secondline therapy for patients with metastatic colon cancer.Materials and methods. we performed a retrospective analysis of data on patients with metastatic colon cancer treated in 9 clinics in the Russian federation. The inclusion criteria were as follows: metastatic or locally advanced colon cancer; treatment with bevacizumab or aflibercept plus fOLfIRI in the second-line therapy. The primary outcome measure was progression-free survival (PfS). Secondary outcome measures included objective response rate and incidence of adverse events.Results. A total of 271 patients with metastatic colon cancer who received second-line therapy with bevacizumab (n = 81) or aflibercept (n = 190) between 2014 and 2018 were selected for this study. Study groups were matched for main prognostic signs. The objective response rate was 18.1 % in the bevacizumab group and 20.5 % in the aflibercept group (p = 0.7). The median PfS was 5 months (95 % confidence interval 3.8–6.1) in the aflibercept group and 7 months (95 % confidence interval 0.81–2.1) in the bevacizumab group (hazard ratio 1.4; 95 % confidence interval 0.99–2.1; p = 0.04). multivariate regression analysis demonstrated that the type of the targeted drug independently had no effect on PfS (hazard ratio 1.3; 95 % confidence interval 0.9–1.9; p = 0.2). we observed no statistically significant differences in the incidence of complications of any grades between the groups (58 % vs 72 %, p = 0.1). Patients receiving aflibercept were more likely to develop grade III–Iv arterial hypertension (2 % vs 9.5 %) and diarrhea (0 % vs 5.4 %), whereas thrombotic complications were more common in the bevacizumab group (10 % vs 1.8 %).Conclusion. we observed no significant differences in objective response rate and PfS between patients with metastatic colon cancer receiving bevacizumab or aflibercept in combination with fOLfIRI as second-line therapy. The toxicity profiles were different. Our findings can be used for choosing an optimal targeted drug for second-line treatment.
Objective: to identify factors associated with efficacy of an aflibercept-chemotherapy combination in patients with metastatic colon cancer. Materials and methods. This retrospective multicenter study was conducted in 20 clinics from 15 regions of the Russian Federation. The main efficacy outcome was progression-free survival (PFS). We performed univariate and multivariate analysis to assess the impact of various factors of PFS. Results. Two hundred and fifty-seven patients received aflibercept-containing chemotherapy; of them, 175 participants (68.1 %) received it as a second-line therapy. The objective response rate and median PFS were 18.7% and 5 months (95% confidence interval (CI) 4.2—5.8) respec -tively. The following factors were found to have a positive effect of PFS at multivariate analysis: grade I—II adverse events to aflibercept therapy (hazard ratio (HR) 0.58; 95 % CI 0.38—0.89; p = 0.01), therapy for concomitant diseases (HR 0.47; 95 % CI 0.29—0.76; p = 0.002), and ECOG performance status of 0 (HR 0.53; 95 % CI 0.34—0.81; p = 0.004). Patient with all 3 factors present had median PFS of 9 months, whereas patients without them demonstrated PFS of only 3 months (HR 1.9; 95 % CI 1.5—2.6; p <0.001). Conclusions. Satisfactory performance status, adequate therapy for concomitant diseases, and adverse events to aflibercept therapy were associated with better PFS in patients receiving aflibercept-containing chemotherapy.
Objective: to identify factors associated with efficacy of an aflibercept-chemotherapy combination in patients with metastatic colon cancer.Materials and methods. This retrospective multicenter study was conducted in 20 clinics from 15 regions of the Russian Federation. The main efficacy outcome was progression-free survival (PFS). We performed univariate and multivariate analysis to assess the impact of various factors of PFS.Results. Two hundred and fifty-seven patients received aflibercept-containing chemotherapy; of them, 175 participants (68.1 %) received it as a second-line therapy. The objective response rate and median PFS were 18.7% and 5 months (95% confidence interval (CI) 4.2—5.8) respec -tively. The following factors were found to have a positive effect of PFS at multivariate analysis: grade I—II adverse events to aflibercept therapy (hazard ratio (HR) 0.58; 95 % CI 0.38—0.89; p = 0.01), therapy for concomitant diseases (HR 0.47; 95 % CI 0.29—0.76; p = 0.002), and ECOG performance status of 0 (HR 0.53; 95 % CI 0.34—0.81; p = 0.004). Patient with all 3 factors present had median PFS of 9 months, whereas patients without them demonstrated PFS of only 3 months (HR 1.9; 95 % CI 1.5—2.6; p <0.001).Conclusions. Satisfactory performance status, adequate therapy for concomitant diseases, and adverse events to aflibercept therapy were associated with better PFS in patients receiving aflibercept-containing chemotherapy.
Purpose . To assess the incidence and severity of adverse events; to explore clinical factors associated with grade 3–4 non-hematologic toxicity; to assess the immediate efficacy and progression-free survival during treatment with the FOLFIRI regimen in combination with aflibercept in Russia. Materials and Methods . A retrospective multicenter study has been conducted with data collected from 20 clinics in 15 regions of Russia. There was no statistical hypothesis. Progression-free survival was the main efficacy criterion. The statistical analysis was performed using IBM SPPS Statistics v. 20 software. Results . FOLFIRI and Aflibercept combination was administered to 264 patients. The mean number of treatment cycles was 6 (1 to 29). The toxicity of aflibercept was addressed by dose reduction and dosing delay in 10.1 % and 11.4 % of patients, respectively, and dose reductions and dosing delays in any of FOLIFRI components were reported in 20.1 % of participants. The objective response rate was 20.3 %. The median progression-free survival in patients receiving second-line treatment was 6 months (95 % CI: 5.3–6.6 months). Seventy-two percent of patients experienced any grade of adverse events most of which were limited to grade 1–2 (62.1 %). Non-hematologic toxicity was reported in 64 % of patients (grade 3–4 in 17.9 %). Hematologic events were detected in only 17.9 % of patients. Multifactorial analysis has shown that drug therapy for concomitant diseases (OR 1.98, 95 % CI: 1.04–3.78, p = 0.037) and the number of chemotherapy lines prior to aflibercept (ОR 1.5, 95 % CI: 1.06–2.11, p = 0.02) were independent predictors of grade 3–4 non-hematologic toxicity. Conclusions . Objective response rate, progression-free survival, and frequency of toxicity-related aflibercept discontinuations in the Russian study with patients receiving aflibercept in combination with FOLFIRI regimen as a second-line treatment has shown the results that were comparable with VELOUR study. Comorbidities requiring drug treatment and the number of prior chemotherapy lines appear to be risk factors for grade 3–4 nonhematological toxicity events.
Purpose. To assess the incidence and severity of adverse events; to explore clinical factors associated with grade 3–4 non-hematologic toxicity; to assess the immediate efficacy and progression-free survival during treatment with the FOLFIRI regimen in combination with aflibercept in Russia.Materials and Methods. A retrospective multicenter study has been conducted with data collected from 20 clinics in 15 regions of Russia. There was no statistical hypothesis. Progression-free survival was the main efficacy criterion. The statistical analysis was performed using IBM SPPS Statistics v. 20 software.Results. FOLFIRI and Aflibercept combination was administered to 264 patients. The mean number of treatment cycles was 6 (1 to 29). The toxicity of aflibercept was addressed by dose reduction and dosing delay in 10.1 % and 11.4 % of patients, respectively, and dose reductions and dosing delays in any of FOLIFRI components were reported in 20.1 % of participants. The objective response rate was 20.3 %. The median progression-free survival in patients receiving second-line treatment was 6 months (95 % CI: 5.3–6.6 months). Seventy-two percent of patients experienced any grade of adverse events most of which were limited to grade 1–2 (62.1 %). Non-hematologic toxicity was reported in 64 % of patients (grade 3–4 in 17.9 %). Hematologic events were detected in only 17.9 % of patients. Multifactorial analysis has shown that drug therapy for concomitant diseases (OR 1.98, 95 % CI: 1.04–3.78, p = 0.037) and the number of chemotherapy lines prior to aflibercept (ОR 1.5, 95 % CI: 1.06–2.11, p = 0.02) were independent predictors of grade 3–4 non-hematologic toxicity.Conclusions. Objective response rate, progression-free survival, and frequency of toxicity-related aflibercept discontinuations in the Russian study with patients receiving aflibercept in combination with FOLFIRI regimen as a second-line treatment has shown the results that were comparable with VELOUR study. Comorbidities requiring drug treatment and the number of prior chemotherapy lines appear to be risk factors for grade 3–4 nonhematological toxicity events.
e15570 Background: Ramucirumab is the first anti-angiogenic targeted agent to demonstrate improved survival as monotherapy or in combination with CT among patients with disseminated stomach cancer. Methods: Under our supervision there were 24 patients: 12 men (50%) and 12 women (50%), from 29 to 72 years old, the median age was 52 years (95% CI 43.56-60.32). The median time to diagnosis of the 4th stage of the disease was 2 months (95% CI 0-11.44). All patients received 1 line of treatment; the median duration of 1-line therapy was 5 months (95% CI 4.00-6.83). Results: The duration of therapy with ramucirumab ranged from 2 to 16 months; median duration was 5.0 months (95% CI 3.00-7.44). The therapy with ramucirumab in 11 patients (45.83%) was followed by SD, in 3 patients (12.50%) - PR, in 4 patients (16.67%) - PD, and in 6 patients (25 , 00%) assessment of the effectiveness of therapy was not conducted due to the deterioration of the general condition during treatment. Thus, the ORR was 58.33%. The median overall survival was 18 months (95% CI 14–23). In order to identify adverse factors affecting overall survival, we constructed a Cox's regression model showing the dependence of overall survival on unfavourable prognosis factors. In general, the constructed model was reliable - p = 0.0013. The gender of the patients (p = 0.0642), the time before staging the 4th stage of the disease (p = 0.4312) and the duration of the 1st line therapy (p = 0.8675) did not have a significant effect on the survival of patients. Such factors as the patients' age (p = 0.0121), the localisation of the primary tumor (p = 0.0441), the differentiation of the tumor (p = 0.0095), the fact of removal of the primary tumor (p = 0.0133) had a significant impact, general status on the ECOG scale (p = 0.0250), the presence of anemia (p = 0.0192), damage to the peritoneum (p = 0.0022) and damage to metastases of more than 3 organs (p = 0.0062). Conclusions: An increase in OS in patients who received a combination of ramucirumab and paclitaxel can be considered clinically significant for this patient population and will allow considering this therapeutic regimen as a new standard of second line treatment of patients with poor prognosis of gastric cancer.
The incidence and mortality of skin melanoma in the world and in Russia is growing every year. It should be noted that the proportion of patients with melanoma of late stages remains high. Until recently, only ineffective chemotherapy regimens were available for such patients. That is why the possibility of using modern drugs in real clinical practice for the treatment of this cohort of patients is an urgent issue of modern clinical oncology. The appearance in a real clinical practice of a new group of immunological drugs (anti-CTLA4 and anti-PD-1) for the treatment of patients with metastatic melanoma allows to increase both the time to progression and the life span of this cohort of patients.In this article, we present the experience of St. Petersburg Regional Clinical Hospital “City Clinical Oncology Clinic” in the treatment of patients with metastatic melanoma under the conditions of real clinical practice with the preparation of ipilimumab as part of the expanded access program from February 2014 to March 2017. In total, 31 patients with disseminated melanoma (12 men and 19 women) were treated with ipilimumab during this period. The average age was 57 years (from 39 to 81 years), in 8 patients there were metastases to the brain. Patients with ECOG status 1 at the time of initiation of treatment were the majority 28 patients (90%), three patients (10%) had ECOG status 2. All patients had previously received 1 to 4 lines of systemic chemotherapy. The median of the observation period is currently 12 (3-35) months. The median time to progression was 6 months. At 5 of 31 patients at the time of analysis, signs of progression were not identified. The median overall survival (OB) was 12 months 9 of 31 patients were alive at the time of the analysis. The annual OM was 56.5%, the 2-year period was 29.4%.The article presents a clinical case of treatment of a patient with metastatic melanoma, which will have an effect against the progression of the disease after four lines of therapy, including ipilimumab. The patient was included in the program of expanded access to the PD-1 inhibitor, nivolumab. In all, the patient received 65 nivolumab injections. The life expectancy of the patient from the moment of diagnosing the metastatic stage of the disease is 3.5 years, while 2.5 years on the background of nivolumab therapy. Patient monitoring continues.
Aim.To evaluate the effectiveness of different regimens of maintenance chemotherapy after the first line of treatment for patients with metastatic colorectal cancer.Materials and methods.We performed retrospective analyses of the data from 432 patients from 17 clinics in 14 regions of the Russian Federation who started systemic therapy for metastatic cancer in 2013. The main inclusion criterion was objective response or stabilization after the first 16 weeks of first-line therapy. Four groups of patients were compared, depending on the nature of maintenance therapy: those receiving fluoropyrimidines, a combination of fluoropyrimidines with bevacizumab, monotherapy of bevacizumab and monotherapy of anti-EGFR antibodies. The main criteria for assesment of the effectiveness of treatment were progression-free survival and overall survival. The statistical analysis was performed with the SPSS 20.0 sof tware package.Results.Maintenance therapy after completion of the first 16 weeks of the 1st line of chemotherapy was administered in 126 patients, most of them were treated with fluoropyrimidines (53.1 %). The median overall survival in the maintenance group was 27 versus 21 months in the observation group, p=0.01, HR=0.78 (95 % CI 0.6–1.02) Median progression-free survival in the maintenance group was 11 vs 7 months in the observation group (p<0.001, HR=0.6, 95 % CI 0.5–0.8). The worst results of progression-free survival were observed in the group with monotherapy of bevacizumab – median was 10 months versus 12 months in the fluoropyrimidine monotherapy group, 10 months for the combination of fluoropyrimidine with bevacizumab and 14 months for monotherapy of the anti-EGFR (p=0,9, HR=1.0, 95 % CI 0.9–1.2).Conclusions.There were no statistical differences in survival with different regimens of maintenance therapy. Monotherapy of bevacizumab in maintenance treatment was associated with the worst sur vival rates.
Background. Gastric cancer is the fifth most common malignancy worldwide with diagnosis often occurring at an advanced stage. For the majority of advanced gastric cancer patients, chemotherapy typically is used as first-line treatment, although many patients will also require second-line treatment. Ramucirumab (Cyramza®, Eli Lilly and Company, Indianapolis, Indiana, USA) recently has received worldwide and United States Food and Drug Administration approval for gastric cancer in the second-line setting. Case reports. A series of five advanced gastric cancer cases is presented, outlining each patient’s diagnosis and treatment. All patients were treated with intravenous ramucirumab (8 mg/kg on days 1 and 15) plus paclitaxel (80 or 100 mg/m2 on days 1, 8, and 15 of a 28-day cycle) after disease progression on or after first-line chemotherapy. Patient outcomes are described including an outline of treatment-related adverse events and quality of life. All patients were able to achieve a clinical response and stable disease. Conclusion. Our case series demonstrates that ramucirumab, in conjunction with paclitaxel, is an effective and well-tolerated treatment option for advanced gastric cancer patients who have disease progression following first-line chemotherapy.
e18022 Background: In Russia, there are no federal screening programs for detecting early stage of colon cancer; therefore we can assess the impact of various factors that could potentially affect the mortality of pts with mCRC Methods: We conducted a survey with 13 question according treatment of pts with CRC in 17 regional comprehensive cancer centers in 14 regions of Russia, with a total population of 26.347 billion. Results of the survey were conducted by methods of descriptive statistics. Effects of factors on mortality rate in regions were analyzed by a regression model Results: Only 34% pts with stage II-III received adjuvant chemotherapy. Mutation status of KRAS gene has been evaluated only in 33% pts with mCRC. In 2013, metastasectomy was performed only 13% of pts. Only 80% of pts who needed systemic treatment received chemotherapy (CT): doublets of CT (XELOX/FOLFOX/FLOX or FOLFIRI/XELIRI/IFL) - 49%, monotherapy of fluoropyrimidines - 39% of pts, bevacizumab – in 14% and anti-EGFR antibodies - 5% pts. Only 14% of pts with mCRC was placed central vein devices. Second line CT was performed in 47% pts: doublets – in 54%, monotherapy of fluoropyrimidines - in 24% pts, bevacizumab - 13% and anti-EGFR antibody - 8%. Third-line treatment was performed in 25% of pts: anti-EGFR antibodies - in 7.5%. According to regression analysis adjuvant chemotherapy (р = 0.01), bevacizumab only in the 1st line (р = 0.01), and installation of central venous devises (р = 0.07) and anti-EGFR antibody in the 1st line (р = 0.1) in wtKRAS pts had independent positive effect on the mortality rate in regions. We revealed a significant reverse connection between a high mortality rate in the region and administration of fluoropyrimidine monotherapy as 1st line treatment of metastatic disease (p = 0.01) Conclusions: The mortality with colorectal cancer is depended of complex factors that reflect the health care organization in the region, both at the stage of treatment of pts with early-stage and metastatic disease. We revealed that targeted agents are the most effective only in the 1st line settings.
e17519 Background: The purpose of our study was to investigate prognostic role of neutrophil to lymphocyte ratio (NLR), derived neutrophil to lymphocyte ratio (dNLR), platelet to lymphocyte ratio (PLR), and lymphocyte to monocyte ratio in PFS and OS, and immunological tumor’s microenvironment in patient with HNSCC. Methods: We analysed medical records an tumor samples of 60 patients with HNSCC with stage I - IVB (37 men, 23 women; median age 59). All patients were under standard clinical complex protocol. All patients were under our supervision from 2010 to 2015. We examined demographic data, clinical stage, tumor morphological characteristics and specific level of expression of CD8(+) T-cells, in the tumor and microenvironment, and baseline level of WBC, neutrophil, lymphocyte, monocyte and PLT . Also we analysed calculated value of NLR, dNLR, PLR, and LMR. Results: The median value of NLR was 2.03 (95% CI: 1.66-2.59), dNLR - 1.44 (95% CI: 1.23-1.70), PLR - 144.58 (95% CI: 107.59-179.32) and LMR - 6.79 (95% CI: 5.34-8.17). Median of 1-year OS and PFS was non significantly lower in pts with NLR < 2.03 (16.0 vs 18.0 month, p = 0.6020 and 5.00 vs 7.00 month, p = 0.5383). But NLR correlate with expression of CD8(+) T-cell in tumor (p = 0.05). Median of 1-year OS was the same in both group (16.0 vs 17.0 month, p = 0.5453), PFS was non significantly lower in pts with dNLR < 1.44 (16.0 vs 18.0 month, p = 0.6020 and (5.00 vs 7.00 month, p = 0.7435). NLR correlate with expression of CD8(+) T-cell in tumor (p = 0.0337). Analyse of LMR showed trend of best 1-year OS in pts with LMR < 6.79 (18.0 vs 15.0 month, p = 0.4674) and equal PFS (6.00 vs 7.00 month, p = 0.4914). PFS and 1-year OS were better (nonsignificant) in pts with PLT > 144.58 (9.0 vs 5.0 month, p = 0.5854) and (18.0 vs 16.0 month, p = 0.5836). Conclusions: Important role of indicators of systemic inflammation is obvious for patient with HNSCC, but our study showed that only baseline characteristics couldn’t be strong prognostic factors by different degree of intratumor inflammation.
According to published randomized studies of second-line therapy in patients diagnosed with gastric cancer, an increase in the median survival with chemotherapeutic agents (docetaxel or irinotecan) is approximately 1.5 months compared with symptomatic therapy. There are data from comparative studies evaluating the effectiveness of other targeted drugs: the use of everolimus as second-line drugs did not reveal a significant increase in OS; studies of anti-EGFR therapy (the addition of panitumumab or cetuximab to chemotherapy) as first-line therapy also did not show a significant increase in OS or PFS, respectively. The increase in OS in patients treated with a combination of ramucirumab and paclitaxel, in comparison with the placebo group and paclitaxel, can be considered clinically significant for this patient population and will allow treating this therapeutic regimen as a new standard of second-line treatment in patients with this nosology.
Introduction: Based on the results of randomized trials, bevacizumab (bev) is effective in 1st, 2nd lines of chemotherapy (CT) and beyond of progression for the entire patients (pts) population. At the same time there is no clear evidence for the effectiveness of bev in case of mKRAS pts, especially, in 2nd line of CT and beyond of progression. We have reviewed the effectiveness of different sequences of combination CT and bev in pts with mKRAS mCRC who received 2 lines of systemic therapy in routine clinical practice Methods: We have collected personal data of 479 pts from 17 clinics in 14 regions of Russia who began to receive 1st line at the quarter of 2013. The criteria for inclusion were the following: presence of mutations in KRAS gene, receiving at least two lines of CT for mCRC. Four groups of pts were formed depending on the combination of bev with CT in 2 lines: CT/CT, CT+bev/CT, CT/CT+bev; CT+bev/CT+bev. Overall survival (OS) was the primary endpoint. Statistical analysis was performed in IBM SPSS statistics v.20 software package Results: Only 97 pts (20%) meet inclusion criteria: CT/CT - 46 (47%), CT+bev/CT - 17 (18%), CT/CT+bev - 21 (22%); CT+bev/CT+bev - 13 pts (13%). Groups were comparable for the main prognostic factors such as number of organs with metastases, presence of adjuvant CT, localization of metastasis, sex, age, removal of the primary tumor. Median follow up was 27 months (6-67). Median OS in the CT/CT group was 22, CT+bev/CT - 27, CT/CT+bev – 21 and CT+bev/CT+bev - 29 months. Results of pairwise comparisons of OS between groups are presented in the table. Conclusion: Our retrospective data showed that combination of CT with bev is effective only in the 1st line of treatment in pts with mKRAS mCRC.
Цель. Оценить качество оказания медицинской помощи больным раком толстой кишки в РФ. Материалы и методы. Проведен опрос 17 клиник 14 регионов РФ (рис. 1), включавший параметры, которые потенциально могут влиять на смертность больных метастатическим раком толстой кишки. Применялся корреляционный и регрессионный анализ ассоциации смертности от рака толстой кишки и данных анкетирования. Результаты. По результатам регрессионного анализа подтверждено обратное влияние на смертность при раке толстой кишки назначения адъювантной химиотерапии после удаления первичной опухоли (р=0,01), назначения бевацизумаба в первой линии терапии (р=0,01), подтверждена тенденция к уменьшению смертности при установке центрального венозного доступа (р=0,07), при назначении анти-EGFR антител в первой линии (р=0,1). Отмечена значимая взаимосвязь между высокой смертностью в регионе и назначением монотерапии фторпиримидинами в первой линии лечения метастатического рака (р=0,01). Выводы. На смертность при раке толстой кишки влияет комплекс факторов, отражающих организацию оказания противоопухолевого лечения в регионе как на этапе лечения больных ранними стадиями (например, назначение адъювантной химиотерапии), так и с метастатическим процессом (например, характер первой линии терапии).
e15505 Background: Inflammation seems to be significant factor in carcinogenesis and tumor progression of numerous cancers. Blood calculated neutrophil-to-lymphocyte ratio (NLR), platelet-to-lymphocyte ratio (PLR), C-reactive protein (CRP), lactate dehydrogenase (LDH), international normalized ratio (INR) can be evaluated as systemic inflammation markers and prognostic biomarker for many aims: survival outcomes, lymph node metastasis and recurrence, treatment responses in a variety of cancers. The purpose of this study was to investigate baseline associations between blood test parameters (NLR, PLR, LDH, CRP, INR) and their prognostic biomarker role for patient with metastatic gastric cancer, undergoing first-line chemotherapy Methods: Potential baseline inflammatory markers (platelets, neutrophils, lymphocytes, the platelet-lymphocyte ratio, the neutrophil-lymphocyte ratio, the serum C-reactive protein [CRP], the serum LDH, INR) were retrospectively analyzed in 32 patients with metastatic gastric cancer, IV stage (median of age – 60,50). Multivariate analyses were used to identify prognostic factors for overall survival (OS). Baseline values were compared with tumor characteristic and median survival times (MSTs). Results: Multivariate analysis identified due to Cox proportional-hazards regression showed significant longest OS in patients with: localization of primary tumor in antral part of gastric (HR 0,45, 95% CI 0,25-0,80, p = 0,0065); low baseline’s level of WBC (HR 1,17, 95% CI 1.02 - 1,35, p = 0,0219); low baseline’s level of neutrophil (HR 1,18, 95% CI 1.02 - 1,34, p = 0,0251). Level of LDH, CRP, INR didn’t show significant ratio for this cohort of patient. Peritoneum metastatic also didn’t significant affect on OS in patient with metastatic gastric cancer. Patients with low baseline’s platelet to lymphocyte ratio (HR 1,004, 95% CI 1,0009-1,0072, p = 0,0125) and low (from 0 to 3,0) neutrophil to lymphocyte ratio (HR 1,81, 95% CI 1,09-2,99, p = 0,0212) had a significantly longest OS time. Conclusions: Inflammatory markers can predict overall survival in stage IV gastric cancer. Simple and useful.
Main indices of efficacy such as objective response and stabilization frequency, objective response median and survival rate were evaluated in 84 patients with disseminated breast cancer receiving different doses of cytostatics: high-dose chemotherapy (HDC) plus transplantation of peripheral blood stem cells, standard-dose (SDC), dose reduced by 20% (RDC20) or by 50% (RDC50). There was an inverse correlation between complete+partial response frequency, on the one hand, and dosage, on the other: highest dose--70% and lowest dose--11.1%. Objective response median in both groups was pretty close--8.5 +/- 5.5 and 5 +/- 0.4% months, respectively. The lowering of dose involved a higher risk of tumor progression from 15% after HDC, 46.6%--SDC and 44.4%--RDC20 to 61.1% after RDC50, with likelihood of objective response decreasing. Nether median nor mean survival rates depended on dosage, nor the difference was significant (p = 0.72). Hence, adequate dose proved to be an important factor, as far as treatment efficacy is concerned. Escalation to high dose was followed by an increase in objective response rates to 70%, SDC - 35.7%, RDC20--33.4% and RDC50--11.1%. Yet, nether dose escalation nor dose reduction involved significant variation in survival (p = 0.72).