Sequential adjuvant docetaxel and anthracycline chemotherapy for node positive breast cancers: a retrospective study.

PURPOSE: Anthracyclines and taxanes are the most active agents in the adjuvant treatment of breast cancer (BC). They can be used simultaneously or sequentially. The optimal schedule and duration for their administration is unknown. We analyzed the efficacy of sequential adjuvant anthracycline and docetaxel administration in node positive BC patients. METHODS: Node positive BC patients (N=539) from 6 medical oncology centers in Turkey who received sequential adjuvant anthracycline-based regimens and taxane chemotherapy were included in this study between 2006 - 2010. One-hundred and thirty-eight (25%) patients received 3 cycles of anthracycline-based chemotherapy followed by 3 cycles of docetaxel (3+3) and 401 (75%) patients received 4 cycles of anthracycline-based chemotherapy followed by 4 cycles of docetaxel (4+4). Prognostic factors analyzed were estrogen receptor (ER), progesterone receptor (PR), HER2, tumor grade, and nodal status in relation to disease free survival (DFS) and HER2 status in relation to overall survival (OS). RESULTS: The patient median age was 48 years (range 18-79). Most common grade 3-4 toxicities were neutropenia, mucositis and arthralgia. No treatment-related toxic deaths were seen. With a median follow up of 26 months (range 1-115) 61 (11.3%) recurrences and 11 (2%) deaths were registered. Three-year DFS was 81% and OS 96% for all patients. There was no statistically significant difference between 3+3 and 4+4 groups in terms of survival (3-year DFS 88% and 79% [p=0.28] and OS 97% and 95% [p=0.60), respectively). CONCLUSION: Sequential chemotherapy with 4+4 cycles of anthracycline and docetaxel every 3 weeks is an acceptable regimen for adjuvant treatment of node positive BC patients. Duration of chemotherapy should be planned depending on prognostic factors. In this study there was no difference between 3+3 and 4+4 groups in DFS and OS despite the presence of good prognostic factors in the 3+3 group.

Adjuvant therapy for gallbladder and bile duct cancers: retrospective comparative study.

PURPOSE: To study the efficacy of adjuvant therapy (chemotherapy and radiotherapy) in early stages (I-III) of gallbladder and bile duct cancers. METHODS: The clinical and pathological characteristics, treatment details and survival data of patients operated with early stages (I-III) of gallbladder and bile duct cancers and followed up in our clinic between August 2002 - November 2009 were retrospectively evaluated. RESULTS: 52 patients (median age 64 years) with early stages of gallbladder (n=36) and bile duct (n=16) cancers were analysed. Twenty-three (44.2%) patients had stage I, 23 (44.2%) stage II, and 6 (11.5%) stage III cancers. Approximately half of the patients (n=25; 48.1%) received postoperative adjuvant chemotherapy and/or radiotherapy. Patients with adjuvant treatment were younger than those without (62 vs. 71 years, p=0.06). Eighteen patients received chemotherapy alone, 2 chemotherapy followed by radiotherapy, 1 chemotherapy concurrently with radiotherapy, and 4 radiotherapy alone as adjuvant therapy. The regimen most frequently used (57.1%) was CFF (cisplatin 50 mg/m(2), day 1; folinic acid 200 mg/m(2), day 1; 5-fluorouracil [5-FU] 400 mg/m(2) bolus day 1 and 1600 mg/m(2) 48h continuous infusion). Some poor prognostic factors like high tumor grade and vascular invasion were more frequent in patients who received adjuvant therapy. The median disease free survival (DFS) was 11.4 months for the patients that received adjuvant therapy vs. 8.2 months for those without adjuvant therapy (p=0.67). During follow up 11 patients (44.0%) with adjuvant therapy and 12 (44.4%) without have died (p=0.97). The estimated median survival was 29 months. CONCLUSION: Although previous studies had shown that 5-FU-based adjuvant chemotherapy may provide a small survival advantage, this was not confirmed in the present study. Prospective adjuvant trials with a standard chemotherapy regimen and larger numbers of patients are required.

Gastric adenocarcinoma under the age of 40; more metastatic, less differentiated.

PURPOSE: Gastric carcinoma is relatively rare under the age of 40 years, and the mean age at presentation is 65 years. Histologically, adenocarcinoma prevails. Previous studies state that gastric adenocarcinoma under 40 is more aggressive. The present retrospective study was undertaken to clarify the clinicopathological characteristics of gastric adenocarcinoma in patients under 40 and to compare their clinical features with the patients over 40 years of age. METHODS: All of the patients with histologically diagnosed gastric adenocarcinoma who had applied to our department from March 2001 to September 2009 were retrospectively evaluated. Patients were stratified according to their age at diagnosis (≤ 40 years; group 1, and > 40 years; group 2). Their clinical, laboratory, and pathological characteristics were analyzed. RESULTS: 251 patients were studied. Sixty-eight percent of those under 40 and 46% over 40 had poorly differentiated histology (p= 0.036). Fifteen (60%) patients under 40 and 73 (32.3%) over 40 had metastatic diseases (p=0.007). CONCLUSION: Younger patients with gastric adenocarcinoma have less differentiated, more advanced and metastatic disease. Patients' complaints, tumor localization, metastatic sites and smoking did not differ significantly between the groups. Controversy for survival parameters still exists.

First-line therapy for metastatic colorectal carcinoma: modified FOLFOX4 or FOLFIRI-bevacizumab.

PURPOSE: The aim of this study was to compare the efficacy and toxicity of modified (m) FOLFOX4 (folinic acid, 5-fluorouracil [5-FU], and oxaliplatin) vs. FOLFIRI-B (folinic acid, 5-FU, irinotecan, and bevacizumab) as first-line treatment of metastatic colorectal carcinoma (MCRC). METHODS: The medical records of 89 MCRC patients treated with either mFOLFOX4 (group 1) or FOLFIRI-B (group 2) as first-line chemotherapy were evaluated retrospectively. RESULTS: Complete (CR) plus partial response (PR) were seen in 18 (36.7%) vs. 13 (32.5%) patients in the mFOLFOX4 vs. FOLFIRI-B, respectively (p=0.67). Median progression-free survival (PFS) was 9 months (95% CI 7.2- 9.5) vs. 10 months (95% CI 7.6-12.3) in group 1 vs. group 2, respectively (p=0.30). Median overall survival (OS) was 22 months (95% CI 17.6-26.3) and 19 months (95% CI 13-24.9) in group 1 and 2, respectively (p=0.32). There was no statistically significant difference in grade 3-4 hematological toxicity between the groups, but grade 3-4 grade weakness, diarrhea, nausea and vomiting was observed more frequently in the FOLFIRI-B patients (p=0.03, p=0.01, p=0.05, respectively). CONCLUSION: Our data suggest that mFOLFOX4 and FOLFIRI-B are equally effective as first-line chemotherapy in MCRC patients. This may partially be explained by the fact that almost 50% of those receiving FOLFOX in the first-line received FOLFIRI-B in the second-gline, an observation suggesting that bevacizumab in the second line may be as effective as in the first line.

Safety and efficacy of FOLFIRI-bevacizumab for metastatic colorectal carcinoma as second line treatment.

PURPOSE: To evaluate the efficacy and the safety of FOLFIRI-bevacizumab (B) in the 2nd line therapy of metastatic colorectal carcinoma (MCRC). METHODS: Between March 2006 and July 2009 35 patients with MCRC were treated with 2nd line therapy FOLFIRI- B (irinotecan 180 mg/m(2) D1, folinic acid 200 mg/m(2) D1, 5-fluorouracil/5 FU 400 mg/m(2) bolus D1, followed by 5 FU 2600 mg/m(2) 46-h continuous infusion, and bevacizumab 5 mg/kg D1, every 2 weeks) Their data were collected and analysed. RESULTS: The patient median age was 54 years (range 36-75). One patient (2.8%) had received oxaliplatin-based adjuvant chemotherapy and 33 patients (94.3%) were exposed to oxaliplatin during first line chemotherapy for MCRC. The median follow up period was 12.2 months (range 1.5-37.9). Complete remission (CR) was achieved in 5.7% of the patients and the sum of CR and partial remission (PR) was 11.4%. Disease control (CR+PR+stable disease/SD) was registered in 74.3% of the patients. During follow up, progression (PD) was seen in 32 (91.4%) patients and 23 (65.7%) patients had died. The median progression free survival (PFS) was 7.4 months (95%CI 5.5-9.3) and the median overall survival (OS) 13 months (95%CI 8.8-17.2). Grade 3-4 toxicity requiring delay of chemotherapy was observed in 12 (34.3%) patients with 10 patients (28.6%) having neutropenia and 2 (5.7%) diarrhea. CONCLUSION: FOLFIRI-B may be an efficient and safe choice in the 2nd line treatment of patients with MCRC previously treated with oxaliplatin.

The efficacy and safety of capecitabine plus bevacizumab combination as first-line treatment in elderly metastatic colorectal cancer patients.

AIM: The optimal treatment in older persons with metastatic colorectal cancer (mCRC) is complicated by a lack of general agreement. The aim of this study was to evaluate the activity of bevacizumab plus capecitabine combination in elderly mCRC patients who were not suitable for chemotherapy with irinotecan and oxaliplatin-containing regimens. MATERIALS AND METHODS: Seventy years and older patients with metastatic colorectal carcinoma were included in this retrospective study. Bevacizumab was administered at a dose of 7.5 mg/kg on day 1 as an intravenous (IV) infusion over 30-90 min every 21 days, and capecitabine was prescribed at 1000 mg/m(2) twice daily on days 1-14 of the same 21-day schedule. RESULTS: Eighty-two consecutive patients (47 men, 35 women) were included in the study. The mean age was 75.5 (SD 3.9, range 70-87). Half of the patients were older than 75 years. There were 55 patients (67.1 %) with a good Eastern Cooperative Oncology Group (ECOG) performance status (PS: 0-1) and the remaining 27 patients (32.9 %) had a poor ECOG performance status (PS: 2). With a median follow-up period of 18.5 months, the median progression-free survival (PFS) was 10 months (95 % CI, 7.8-12.1) and the median OS was 25 months (95 % CI, 18.6-31.3). The main toxicities recorded were non-hematological. Thirty-one patients (37 %) experienced grade 3/4 adverse events, the most common being hand-foot syndrome (9.8 %). No fatal toxicity resulting from this regimen was recorded. CONCLUSIONS: Considering the toxicity profile and survival outcomes, the combination regimen of capecitabine and bevacizumab is a potentially feasible treatment option in elderly mCRC patients.