Efficacy of gemcitabine, cisplatin and methylprednisolone [GEM-P] as a salvage regimen for relapsed and refractory lymphoma

The prognosis of relapsed or refractory aggressive lymphomas after primary therapy remains poor. So, there is a continuous need for development of more effective and less toxic salvage regimens. At present, there is no accepted standard salvage chemotherapy. Gemcitabine is effective in treating lymphoma and, when combined with cisplatin, is effective for some solid tumors. The aim of this study was to evaluate efficacy and safety of gemcitabine with cisplatin and methylprednisolone in patients with relapsed and refractory lymphoma. This study had been carried out on 60 patients with relapsed or refractory aggressive lymphomas between August 2009 and July 2012. All patients were treated with GEM-P regimen [Gemcitabine 1000 mg/m[2] on days 1, 8 and 15, Cisplatin 100 mg/m[2] on day 15, and Methylprednisolone 1000 mg on days 1-5] every 28 days. Response assessment was based on Response Evaluation Criteria in Solid Tumors. Toxicity assessment was scaled according to the Common Terminology Criteria for Adverse Events. The best-achieved response rate or overall response rate [ORR] was 41.7 [95% CI 36. 7-46. 7] with twelve patients [20%] obtaining a CR. The median RFS, PFS, and OS were 16 months [95% CI 6.7-25.2], 6 months [95% CI 4.2-7.7], and 20 months [95% CI 12.4-27.5,], respectively. Toxicity of GEM-P regimen was mainly hematological. The incidence of grade 3 and 4 thrombocytopenia was 30% and 15%, while grade 3 neutropenia developed in 30%. There was no treatment-related death. GEM-P is an effective salvage regimen in patients with relapsed and refractory lymphomas with favorable toxicity profile

Evaluation of single dose versus fractionated palliative radiotherapy in breast cancer painful bone metastases

External beam radiotherapy is a well recognized and effective modality in palliation of symptomatic bone metastases, but the optimal dose and fractionation regimen is still debated. In this study, 60 female patients with established diagnosis of breast cancer and painful bone metastases, apart from vertebral column, and not previously irradiated were randomized into two groups. All patients were treated by radiotherapy alone to receive single dose of 8 Gy in one group and 30 Gy fractionated in 10 days in the other group. They were evaluated for pain. mobility, performance status, and analgesic consumption before treatment and weekly for two weeks alter treatment. There was no significant differences in response for either the total score [pain. mobility, performance status and analgesic consumption] or pain score in the two groups. The patients were markedly improved, nearly to the same extent in both groups. There was no advantage of the fractionated treatment as compared to the single dose in pain relief. The results showed that in the majority of patients with painful bone metastases a single fraction of 8 Gy will be as effective as protracted fractionated treatment

Efficacy of pre-operative chemotherapy and sequential radiation therapy in unresectable rectal carcinoma

The aim of this study was to determine the extent of down staging, resectability rate, sphincter preservation and toxicity to preoperative chemotherapy with sequential radiation therapy in the treatment of locally advanced unresectable rectal carcinoma. Between January 2002 and February 2003, 29 patients with a diagnosis of locally advanced unresectable rectal cancer received two cycles of 5-fluorouracil 600 mg/m2, i.v. 6 hr infusion D1-D5 and D22-D26, leucovorin 20 mg/m2, i.v. 1 hr infusion DI-D5 and D22-D26 and cisplatin [CDDP] 60 mg/m2, i.v. 6hr infusion D1 and D22 after good hydration. Radiation treatment was administered after two weeks of the second cycle of chemotherapy. The dose was 45 Gray in 25 fractions over 5 weeks prescribed at iso-center of the plan to include the rectum and the draining lymph node chains. Tumor down-staging occurred in 11 out of 29 patients to whom abdominal resection with sphincter preservation was done and 9 patients with locally advanced rectal cancer were rendered operable and underwent abdominoperineal resection, while the rest of the patients remained inoperable. A total of 3 local recurrences out of 20 resected cases was developed within one year of follow up in the group of patients who underwent anterior abdominal resection, while distant metastases to the liver occurred in three patients whom were inoperable

Primary gastrointestinal non-Hodgkin's lymphoma [PGI NHL]: management and outcome

Sixty-four patients with PGI NHL were included in this study. The study outlined the clinicopathological features, modalities of diagnosis and treatment, outcome and variables affecting the overall survival. The stomach was involved in 36 cases and intestinal lymphoma was implicated in 28 cases. Stage IIE was the commonest stage. The predominant histological type was high-grade. The overall survival in all cases was 63% at 30 months according to the Kaplan Meier method. The stage of the disease, extension of resection, site of the lesion whether gastric or intestinal and achievement of complete remission [CR] were found to affect the overall survival

Adjuvant cisplatin with concurrent radiation therapy for resectable locally advanced carcinoma of head and neck

This randomized prospective study was performed to evaluate the efficacy and toxicity of postoperative concomitant chemoradiation for patients with locally advanced [stages III and IV] but operable squamous cell carcinoma of head and neck region. Eligible patients had completely resected tumor and histological evidence of extracapsular spread of metastatic lymph node or positive surgical margins. The patients were randomized to receive postoperatively either conventional radiotherapy alone [60 Gy] or concomitant cisplatin [100 mg/m2] on day 1, 22 and 43 and radiotherapy [60 Gy]. A total of 37 patients were entered into this study. At a median follow up of 23.7 months in both groups, the locoregional failure rates at 2 years were 50% and 36.8% in radiotherapy and chemoradiotherapy arms, respectively. The difference was not statistically significant. Although the incidence of distant metastasis was reduced by the addition of chemotherapy but it was not statistically significant. The 2-year disease free survival and overall survival were 38.9% and 50% in radiotherapy group compared with 52.6% and 57.9% in chemoradiotherapy group. The differences were not statistically significant. The chemotherapy was satisfactorily well tolerated and did not affect the ability to deliver the radiotherapy. The most common treatment related toxicity was mucositis, in the combined group, 5 patients [26%] developed severe mucositis that necessitated treatment interruption versus only 2 patients [11%] in the RT group. The study concluded that postoperative concomitant cisplatin and radiotherapy for patients with high risk resectable locally advanced head and neck carcinoma improves the locoregional control, together with improvement in both the 2-year disease free and overall survival. This seems to be true despite of not reaching the 5% level of significance, which may be due to the relatively small sample size

Cisplatin and paclitaxel concomitant with radiotherapy in locally recurrent cancer cervix

Twenty-three eligible patients with locally recurrent cervical carcinoma after radical hysterectomy were treated with concomitant cisplatin/paclitaxel and radiation. Thechemotherapy regimen consisted of cisplatin [20 mg/m2] and paclitaxel [45 mg/m2 therapy] that were given every other week concomitantly with 65-70 Gy local pelvic irradiation over 7 weeks. Eight patients [34.8%] experienced grade 3-4 acute toxicity during treatment. Late morbidity was reported in 4 patients [17.4%]. The chemotherapy related morbidity included mainly hematological toxicity, nausea and vomiting and neurotoxicity. The radiation related morbidity included mainly skin reaction, prostatitis and cystitis. Objective response was achieved in 69.7% ofpatients [34.8% complete response and 34.8% partial response]. The median duration of follow up for whole group was 17.1 months. Sex patients [26.9%] were alive with no evidence of disease with a median survival of 30.6 months. The 2 year overall survival was 26.9%. Five patients [21.7%] developed distant metastases. There was a tendency towards better results for earlier initial stage of the disease, patients older than 50 years old, squamous cell carcinoma tumors, tumors < 5 cm, central pelvis tumors and disease free interval from initial surgery more than 1 year. The study concluded that concomitant cisplatin/paclitaxel and radiation is a safe and tolerable treatment with reasonable response rate and satisfying survival for locally recurrent cancer cervix. However, this regimen must be run on a larger number of patients with a longer follow up period to get significant predictors of the response and survival and to guide in identifying the subset of patients that may benefit from more aggressive therapy

prognostic value of interleukin-6 [IL-6] and C-Reactive protein [CRP] in non-hodgkin's lymphoma [NHL]

The prognostic value of two simple serum markers [IL-6 and CRP] was prospectively studied in 40 newly diagnosed patients with non- Hodgkin's lymphoma treated with standard CHOP or CVP chemotherapy regimen for high and intermediate grade or low grade, respectively, who fulfilled the criteria for inclusion in the study. In addition, 20 healthy volunteers served as a control group were included in this study. The significance of these markers was compared with other known prognostic indicators by the statistical analysis. The study revealed a strong correlation between IL-6 and CRP in NHL patients as regards the response and prognostic factors. In unvaried analysis, the age, stage, tumor mass, pretreatment serum albumin, LDH, IL-6 and CRP levels were found to have an influence on the remission rate; where IL-6 and CRP were decreased to a normal level in patients who underwent a complete response [IL-6 mean +/- SD = 7.6 +/- 2.3, CRP mean +/- SD = 6.1 +/- 2.80] and increased in relapsed patients [IL-6 mean +/- SD = 34 +/- 8.9, CRP mean +/- SD = 36 +/- 13.21]. However, in the regression analysis to the results of 33 cases with high and intermediate grade, the pre-treatment IL-6 and CRP levels were the only predictors for remission

Evaluation of efficacy and toxicity of 186RE-HEDP in palliation of breast cancer painful bone metastases

This study included 20 female, breast cancer patients with painful bone metastases, presented to Radiation Oncology Department and Nuclear Medicine Unit, Assiut University Hospital, Faculty of Medicine, Assiut University in the period from July 1999 to April 2001. Their mean age was 46.7 years [range 32-61 years]. They were evaluated consecutively, for the efficacy of 186Re-hydroxyethylidene diphosphonate [HEDP] on pain from bone metastases and the toxicity of this agent. 30 mCi of 186Re-HEDP was intravenously administered for each patient, after performing a baseline bone scan with 99mTc-MDP, followed by 24-hour bone scan with the injected rhenium agent. All patients were followed up bi-weekly in the first month then monthly by clinical and laboratory assessment up to three months. Bone scan with 99mTc-MDP was repeated on day 45 and day 90 for evaluation of bone metastases. The results revealed that 19 patients were evaluated for response [one patient was excluded due to acute evolution of her disease and receiving chemotherapy during the period of response assessment]. An objective response was observed in 78.9% of patients with a mean duration of 58 days, nine patients [47.4%] were relieved of pain during the second week and another six patients [31.5%] enjoyed pain relief during the third week; while, the rest of patients [21.1%] continued complaining of pain, three patients [15.7%] without increase intensity, and one patient [5.3%] with increased pain intensity. No major adverse effects were observed. Marrow toxicity did not exceed grade II for white blood cells and grade III for platelets using National Cancer Institute criteria. In conclusion, 186Re-HEDP provides safe symptomatic relief of pain for bone metastases of breast cancer with correctable minimal adverse effects

Evaluation of combined hyperfractionated radiotherapy and chemotherapy in locally advanced irresectable carcinoma of the pancreas

Thirty-two patients with locally advanced irresectable adenocarcinoma of the pancreas were treated with hyperfractionated radiotherapy and simultaneous application of 5-fluorouracil. Chemotherapy was administered as short infusion before each fraction of radiotherapy for four days in the first week to be repeated on the fourth week according to toxicity. Radiotherapy consisted of two fractions per day for five days per week during four consecutive weeks up to a total dose of 48 Gy, each fraction 1.2 Gy with interfraction period not less than six hours. The median survival time for all patients was 12.7 months compared with three and seven months after palliative radiotherapy alone [historical control]. Toxicity and therapy induced morbidity were recorded according to WHO criteria and were acceptable. This combined modality treatment consisting of hyperfractionated radiotherapy and chemotherapy seems to be feasible for patients with locally advanced and irresectable pancreatic cancer

Tamoxifen in patients with advanced epithelial ovarian cancer

Fifty patients with advanced [FIGO] [stage III and IV] epithelial ovarian cancer were treated with tamoxifen 20 mg twice daily. Their estrogen receptor status was unknown. All patients had progressive or recurrent disease after first or second-line chemotherapy. The objective response rate was 56 percent [28 patients]. Partial responses were observed in 12 patients [24 percent], while sixteen patients [32 percent] showed stable disease. The median duration of objective responses was 7.5 months [range 4-13 months].The median survival of responding patients was 9 months [range 6-16 months].Toxicity was limited. Tamoxifen could be considered for palliation in patients with advanced pretreated epithelial ovarian carcinoma, as well as patients who cannot tolerate chemotherapy