Radiation therapy in chronic hidradenitis suppurativa: case report.

A 26-year-old female presented recurrent painful, carbuncles at both axillae for 10 years. It caused offensive odor and scar. Tissue diagnosis was chronic hidradenitis suppurativa. She was treated using antibiotics followed by multiple excisions with drainage but showed no improvement. Isotretinoin provided no benefit. She was socially isolated and experienced lower quality of life. Consequently, she was sent for radiation therapy. Computed tomography simulation was performed revealing an ulcer with deep chronic pus tracts at her axilla. Three-dimensional conformal radiation therapy was provided with 6 MV photon (7.5 Gy in 3 fractions) covering all ulcers and pus tracts. On the last day of radiation therapy, carbuncles and wounds at the left axilla exhibited much improvement without pus. Three months follow-up showed much improvement of the lesions. The skin was smoother without pus or odor. Radiation therapy was confirmed one treatment option for chronic hidradenitis suppurativa.

A randomized controlled trial comparing concurrent chemoradiation versus concurrent chemoradiation followed by adjuvant chemotherapy in locally advanced cervical cancer patients: ACTLACC trial.

OBJECTIVE: To compare response rate and survivals of locally advanced stage cervical cancer patients who had standard concurrent chemoradiation therapy (CCRT) alone to those who had adjuvant chemotherapy (ACT) after CCRT. METHODS: Patients aged 18-70 years who had International Federation of Gynecology and Obstetrics stage IIB-IVA without para-aortic lymph node enlargement, Eastern Cooperative Oncology Group scores 0-2, and non-aggressive histopathology were randomized to have CCRT with weekly cisplatin followed by observation (arm A) or by ACT with paclitaxel plus carboplatin every 4 weeks for 3 cycles (arm B). RESULTS: Data analysis of 259 patients showed no significant difference in complete responses at 4 months after treatment between arm A (n=129) and arm B (n=130): 94.1% vs. 87.0% (p=0.154) respectively. With the median follow-up of 27.4 months, 15.5% of patients in arm A and 10.8% in arm B experienced recurrences (p=0.123). There were no significant differences of overall or loco-regional failure. However, systemic recurrences were significantly lower in arm B than arm A: 5.4% vs. 10.1% (p=0.029). The 3-year progression-free survival (PFS) and 3-year overall survival (OS) of the patients in both arms were not significantly different. The hazard ratio of PFS and OS of arm B compared to arm A were 1.26 (95% CI=0.82-1.96; p=0.293) and 1.42 (95% CI=0.81-2.49; p=0.221) respectively. CONCLUSIONS: ACT with paclitaxel plus carboplatin after CCRT did not improve response rate and survival compared to CCRT alone. Only significant decrease of systemic recurrences with ACT was observed, but not overall or loco-regional failure. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT02036164, Thai Clinical Trials Registry Identifier: TCTR 20140106001.

Asian expert recommendation on management of skin and mucosal effects of radiation, with or without the addition of cetuximab or chemotherapy, in treatment of head and neck squamous cell carcinoma.

With increasing numbers of patients with unresectable locoregionally advanced (LA) head and neck squamous cell carcinoma (HNSCC) receiving cetuximab/radiotherapy (RT), several guidelines on the early detection and management of skin-related toxicities have been developed. Considering the existing management guidelines for these treatment-induced conditions, clinical applicability and standardization of grading methods has remained a cause of concern globally, particularly in Asian countries. In this study, we attempted to collate the literature and clinical experience across Asian countries to compile a practical and implementable set of recommendations for Asian oncologists to manage skin- and mucosa-related toxicities arising from different types of radiation, with or without the addition of cetuximab or chemotherapy. In December 2013, an international panel of experts in the field of head and neck cancer management assembled for an Asia-Pacific head and neck cancer expert panel meeting in China. The compilation of discussion outcomes of this meeting and literature data ultimately led to the development of a set of recommendations for physicians with regards to the approach and management of dermatological conditions arising from RT, chemotherapy/RT and cetuximab/RT, and similarly for the approach and management of mucositis resulting from RT, with or without the addition of chemotherapy or cetuximab. These recommendations helped to adapt guidelines published in the literature or text books into bedside practice, and may also serve as a starting point for developing individual institutional side-effect management protocols with adequate training and education.

Phase II study of capecitabine (Ro 09-1978) in patients who have failed first line treatment for locally advanced and/or metastatic cervical cancer.

PURPOSE: The objective of this study is to evaluate the efficacy and safety of capecitabine in cervical cancer patients who have locoregional failure and/or distant metastasis and failed first line therapy. The efficacy of capecitabine is determined by the overall response rate (ORR) according to WHO criteria for response and the safety by adverse event (AE) and tolerability profiles according to NCI CTC version 2.0. PATIENTS AND METHODS: Patients with loco-regional failure and/or metastatic cervical cancer who have failed first line therapy were enrolled into the study. The patient received capecitabine 1, 250 mg/m2 twice daily for 14 consecutive days with 7 days rest (21-day cycle). The treatment was continued for up to six cycles. RESULTS: Forty-five patients previously treated by single or combination of surgery, or chemotherapy or radiotherapy were enrolled for study. Thirty-seven of 45 patients (82%) received at least 2 cycles of treatment and they were evaluated for response. The intention to treat analyses revealed 6/45(13%) ORR, 1/45 (2%) CR and 5/45 (11%) PR. Twenty-four patients (53%) had stable disease and 20% had progression of the disease. The median time to progression was 4. 1 months and the median overall survival was 9.3 months. CONCLUSION: Capecitabine as a monotherapy has a modest response in locoregional failure and/or metastatic cervical cancer who have failed first line therapy.

Capecitabine-based chemoradiotherapy with adjuvant capecitabine for locally advanced squamous carcinoma of the uterine cervix: phase II results.

OBJECTIVES: Cisplatin-based chemoradiotherapy is the standard treatment for locally advanced cervical cancer but causes considerable toxicity. Capecitabine and radiotherapy show preclinical synergy and clinical activity. The activity, tolerability, and oral administration of capecitabine make it an attractive adjunctive therapy. METHODS: In this phase II study, patients with untreated International Federation of Gynecology and Obstetrics stage IIB-IIIB cervical cancer received capecitabine, 825 mg/m(2) twice daily (Monday-Friday), during radiation (45 Gy per 25 fractions external-beam radiotherapy and 26 Gy high-dose rate brachytherapy to point A, maximum 8 weeks), followed by six cycles of capecitabine, 1,000 mg/m(2) twice daily (days 1-14 every 21 days). RESULTS: The overall response rate in 60 patients was 88% (95% confidence interval [CI], 77.4%-95.2%), including complete responses (CRs) in 80% of patients. The 1-year progression-free and overall survival rates were 86% (95% CI, 77%-95%) and 95% (95% CI, 89%-100%), respectively. At 23 months, 76% of patients were progression free (95% CI, 65%-88%) and CR was maintained in 90% (95% CI, 81%-99%) of the 48 patients achieving a CR. There were three grade 3 or 4 treatment-related events: reversible grade 4 hypokalemia, grade 3 diarrhea, and grade 3 hand-foot syndrome. CONCLUSIONS: Capecitabine-based chemoradiotherapy with adjuvant capecitabine is a well-tolerated option with an early signal of efficacy meriting further evaluation.

A randomized phase III trial of concurrent chemoradiotherapy in locally advanced cervical cancer: preliminary results.

OBJECTIVE: Concurrent chemoradiation is the standard treatment for locally advanced cervical cancer. This study was a preliminary result of a randomized two arms, prospective, open-label phase III trial comparing the activity and safety of the concurrent chemoradiation of Tegafur-Uracil and carboplatin or carboplatin alone in locally advanced cervical cancer. MATERIALS AND METHODS: The stage IIB-IIIB cervical cancer patients were randomized to have Tegafur-Uracil 225 mg/m(2)/day orally, 5 days a week and carboplatin 100 mg/m(2) IV over 30-60 min, weekly on day 1 concurrent with standard radiotherapy (Group A) or carboplatin alone concurrent with standard radiotherapy (Group B). RESULTS: Four hundred and sixty-nine patients were randomized to Group A (n=234) or Group B (n=235). The tumor response at 3-month follow-up time showed no significant difference. The only prognostic factor to improve the complete response rate was the hemoglobin level. The patients in Group A, who had Hb <10 gm/dL had the relatively better change to complete response of 1.48 compared to that in Group B (P 0.025, 95% CI 1.07, 2.04). No severe toxicity or adverse event had been reported. The median follow-up time for Group A and Group B was 12.6 and 11.8 months, respectively. There was no statistical difference in PFS and OS. CONCLUSION: Concurrent chemoradiation by Tegafur-Uracil and carboplatin showed no difference in tumor response rate or treatment toxicity compared to carboplatin alone. The combination drugs might have benefit in poor prognostic patients such as the baseline Hb <10 gm/dL.

Pain and quality of life of cancer patients: a multi-center study in Thailand.

OBJECTIVE: To identify the association between Quality Of Life (QOL) and pain intensity, and the magnitude of change of pain scores that have a clinically significant impact on patients' QOL. DESIGNS: Multi-center; prospective cohort study. MATERIAL AND METHOD: Patients suffering from cancer pain were recruited from seven university hospitals and three tertiary care centers in Thailand. The FACT-G and the Brief Pain Inventory were used to assess QOL and cancer pain severity, respectively, at study entry and at two-week follow-up. RESULTS: Five-hundred-and-twenty patients were recruited with a mean age of 52. The majority (76%) reported two sites of pain with 80% being treated at either step 2 or 3 (WHO guidelines of pain management). After two weeks, the average level of maximum pain was reduced from 6.6 to 4.8 (mean difference = -1.8, p < 0.001) and the QOL was improved from 58.6 to 61.0 (mean difference = 2.4, p < 0.001). There was a high correlation between the average change of pain intensity and QOL scores (rs = -0.42, p < 0.001). The results show that changes of pain scores of at least three points (3 out of 10) were required for a minimal important difference of FACT-G scores, indicating a significant change on patients' QOL. Pain deterioration had slightly more impact on QOL than pain improvement. A 3-point pain deterioration impaired QOL 10.3 points while 3-point reduction increased QOL only 7.6 points. CONCLUSION: The present findings suggest the importance of pain management. The change of pain scores of at least three points (out of 10 points) had statistical and clinical significance to patients' QOL.

Preoperative capecitabine with pelvic radiotherapy for locally advanced rectal cancer (phase I trial).

OBJECTIVE: Phase I multicenter study defined the maximal tolerated dose (MTD), dose-limiting toxicity (DLT) and safety profile of capecitabine in combination with preoperative radiation for patients with locally advanced rectal cancer (LARC). MATERIAL AND METHOD: Patients were treated with oral capecitabine (700, 800, 900, 1000, 1100 and 1200 mg/m2 twice daily continuously) plus preoperative whole pelvic irradiation (45-46 Gy in 23-25 fractions over 5-6 weeks). Surgery was performed at the median of 42 days after chemoradiation treatment. RESULTS: Twenty-seven patients were in this trial. Eighteen patients (3 per dose level) had received capecitabine from 700 mg/m2 twice daily to the highest dose level of 1200 mg/m2 twice daily. There were no grade 3/4 DLTs during dose escalation, a further nine patients were included at the highest capecitabine dose. Two of the twelve patients (16%) receiving capecitabine 1200 mg/m2 twice daily developed grade 3 diarrhea and discontinued treatment. There were no other grade 3/4 adverse events. After capecitabine chemoradiation, 24 of 27 patients (89%) received definite surgery. Primary and lymph node down staging occurred in ten patients (42%). Sphincter-sparing surgery was performed in seven patients (26%) and abdominal-perineal resection was performed in 17 patients (63%). CONCLUSION: Preoperative capecitabine chemoradiation based on continuous daily capecitabine is very well tolerated in patients with LARC. The authors did not reach the MTD in the present study.

Reducing radiation dose to pelvic small bowel in cervical cancer patients treated with Ir-192 intracavitary brachytherapy by using urinary bladder distension.

OBJECTIVES: Several techniques and devices have been used in an attempt to minimize radiation dose to gastrointestinal tract while giving pelvic radiation. We evaluated the effect of urinary bladder distension to displace pelvic small bowel out of intracavitary brachytherapy field to minimize radiation dose to small bowel in cervical cancer patients. MATERIAL AND METHOD: Eleven cervical cancer patients who received Ir-192 intracavitary brachytherapy with tandem and transverse ovoids were included in this study. Oral contrast material was used to visualize pelvic small bowel. Urinary bladder was distended by injection 125-200 ml. normal saline solution. Pelvic radiograph, anteroposterior and lateral view, was performed before and after bladder distention for brachytherapy treatment planning and comparing radiation dose at small bowel. RESULTS: The average maximum radiation dose at small bowel before and after bladder distension were 3123 cGy and 1998 cGy respectively. The summation of small bowel dose was reduced 54.17% (p = 0.002). CONCLUSION: Urinary bladder distension could effectively displace pelvic small bowel and reduce the radiation dose to small bowel from Ir-192 intracavitary brachytherapy in cervical cancer patients.

Reduced recurrence of late hemorrhagic radiation cystitis by WF10 therapy in cervical cancer patients: a multicenter, randomized, two-arm, open-label trial.

BACKGROUND AND PURPOSE: To evaluate the efficacy and the safety of WF10 as adjunct to standard treatment in the management of late hemorrhagic radiation cystitis compared to standard treatment alone. PATIENTS AND METHODS: Cervical cancer patients with Grade 2 or 3 late hemorrhagic radiation cystitis, were randomized and treated with WF10 0.5 ml/kg body weight, diluted in physiological saline or 5% dextrose water 250 ml, intravenous infusions over 2 h on 5 consecutive days, every 3 weeks for 2 cycles plus standard treatment (WF10 group) or standard treatment alone (control group). Fifty patients in each group were evaluated by questioning; urinalysis and cystoscopy during a 1 year follow up. RESULTS: At week 7, 37 patients (74%) in the WF10 group and 32 patients (64%) in the control group showed complete resolution in objective hematuria (P = 0.28). Significantly lower use of antibiotics (P = 0.002) and antispasmodics (P < 0.001) was found in the WF10 group. Among the responders, 24 patients (77%) in the control group experienced recurrent objective hematuria, whereas in the WF10 group only 17 patients (47%) experienced a recurrence (P = 0.01). Recurrence of objective hematuria occurred significantly faster in the control group as evidenced by Kaplan-Meier and log-rank statistics (P = 0.004), suggesting a long-term effect of WF10. Cystoscopy, at the end of the treatment period and after the one year follow up showed overall improvement without significant difference between two groups. No severe toxicity was monitored. CONCLUSIONS: WF10 therapy is a safe, non-invasive and convenient method in the management of late hemorrhagic radiation cystitis. WF10 therapy, as adjunct to standard treatment, has significantly reduced recurrence of objective hematuria, compared to standard treatment alone, during a one year follow up.

Phase III randomized trial comparing LDR and HDR brachytherapy in treatment of cervical carcinoma.

PURPOSE: Intracavitary brachytherapy plays an important role in the treatment of cervical carcinoma. Previous results have shown controversy between the effect of dose rate on tumor control and the occurrence of complications. We performed a prospective randomized clinical trial to compare the clinical outcomes between low-dose-rate (LDR) and high-dose-rate (HDR) intracavitary brachytherapy for treatment of invasive uterine cervical carcinoma. METHODS AND MATERIALS: A total of 237 patients with previously untreated invasive carcinoma of the uterine cervix treated at King Chulalongkorn Memorial Hospital were randomized between June 1995 and December 2001. Excluding ineligible, incomplete treatment, and incomplete data patients, 109 and 112 patients were in the LDR and HDR groups, respectively. All patients were treated with external beam radiotherapy and LDR or HDR intracavitary brachytherapy using the Chulalongkorn treatment schedule. RESULTS: The median follow-up for the LDR and HDR groups was 40.2 and 37.2 months, respectively. The actuarial 3-year overall and relapse-free survival rate for all patients was 69.6% and 70%, respectively. The 3-year overall survival rate in the LDR and HDR groups was 70.9% and 68.4% (p = 0.75) and the 3-year pelvic control rate was 89.1% and 86.4% (p = 0.51), respectively. The 3-year relapse-free survival rate in both groups was 69.9% (p = 0.35). Most recurrences were distant metastases, especially in Stage IIB and IIIB patients. Grade 3 and 4 complications were found in 2.8% and 7.1% of the LDR and HDR groups (p = 0.23). CONCLUSION: Comparable outcomes were demonstrated between LDR and HDR intracavitary brachytherapy. Concerning patient convenience, the lower number of medical personnel needed, and decreased radiation to health care workers, HDR intracavitary brachytherapy is an alternative to conventional LDR brachytherapy. The high number of distant failure suggests that other modalities such as systemic concurrent or adjuvant chemotherapy might lower this high recurrence, especially in Stage IIB and IIIB.

Pattern of local-regional recurrence in patient with early breast cancer after mastectomy: an analysis of 357 cases at King Chulalongkorn Memorial Hospital.

A retrospective review was performed on 357 patients with early stage I-IIIA operable breast cancer who were treated with mastectomy and referred to the clinic at the Division of Radiation Therapy, Department of Radiology, King Chulalongkorn Memorial Hospital between Jan 1991 and Dec 2001. Patients characteristics, treatment modalities and pattern of local and regional failure were evaluated. The median and mean age in the present study were 49 and 50.2 years, respectively. Stage I, II and IIIA were 10.9%, 79.6% and 9.5%, respectively. One hundred and ninety-seven patients (55.2%) received postoperative radiation therapy (RT). Adjuvant chemotherapy was given in 247 patients (69.2%) while 122 patients (34.2%) received adjuvant hormonal therapy. Sixty one patients (17.1%) received both adjuvant chemotherapy and hormonal therapy. However, 12.6% (45/357) did not receive any adjuvant treatment. Median follow up time was 42.6 months (range 6-136 months). Ipsilateral supraclavicular node and chest wall were the most common sites of local-regional recurrence. The chest wall recurrence rate was 10.4% (37/357), which was 16.9% (27/160) in the non postoperative radiation (No RT) group and 5.1% (10/197) in the postoperative radiation (RT) group. For ispilateral supraclavicular node, the recurrence rate was 10.6% (38/357), which was 15.6% (25/160) and 6.6% (13/197) for non RT and RT groups, respectively. The incidence of ipsilateral axilla, ipsilateral internal mammary node and ipsilateral infraclavicular node recurrence rate were 4.2%, 3.6% and 0.8%, respectively. Overall, chest wall and ipsilateral supraclavicular node were the most common sites of local-regional recurrence in early stage operable breast cancer who underwent mastectomy Postoperative adjuvant radiation therapy decreased the risk of local-regional recurrence.

Concurrent mitomycin C, 5-fluorouracil, and radiotherapy in the treatment of locally advanced carcinoma of the cervix: a randomized trial.

PURPOSE: This is a prospective, Phase III multicenter randomized trial to assess the effectiveness of concurrent intravenous mitomycin C, oral 5-fluorouracil (5-FU), and radiotherapy (RT) in locally advanced carcinoma of the cervix. METHODS AND MATERIALS: Between January 1988 and November 1994, 926 patients with locally advanced carcinoma of the cervix, FIGO Stage IIB-IVA, were entered into this study. The patients were randomized into four arms, as follows: Arm 1: conventional RT; Arm 2: conventional RT and adjuvant chemotherapy; Arm 3: conventional RT plus concurrent chemotherapy; Arm 4: conventional RT plus concurrent chemotherapy and adjuvant chemotherapy. Concurrent chemotherapy consisting of intravenous mitomycin C at 10 mg/m(2) was given on Days 1 and 29, and oral 5-FU at 300 mg/day was administered on Days 1-14 and 29-42 during RT. Adjuvant chemotherapy of 5-FU orally at 200 mg/day was given for three courses of 4 weeks, with a 2-week rest every 6 weeks. Six centers participated in the trial. RESULTS: The median follow-up time was 89 months. Acute side effects were generally higher in concurrent arms, but most of the patients tolerated the treatment well. Bone marrow toxicity was also higher in concurrent arms. The 5-year actuarial disease-free survival (DFS) was 48.2%, 54.1%, 64.5%, and 59.7% for arms 1, 2, 3, and 4, respectively. The pattern of failure revealed a significant increase in locoregional recurrence in the nonconcurrent chemoradiotherapy arm. The local recurrence was 25.5%, 20.6%, 14.3%, and 17.6% for arms 1, 2, 3, and 4, respectively. The metastatic rates were not significantly different in all four arms. At the time of analysis, there were no increases in late side effects, especially in gastrointestinal and genitourinary systems. CONCLUSIONS: Concurrent chemotherapy, mitomycin C, and 5-FU together with conventional RT showed an improved DFS rate when compared with conventional RT alone in patients with locally advanced carcinoma of the cervix.

Estrogen and progesterone receptors status in Thai female breast cancer patients: an analysis of 399 cases at King Chulalongkorn Memorial Hospital.

A retrospective review was performed on 576 patients who have been diagnosed breast cancer and referred to Division of Radiation Therapy, Department of Radiology, King Chulalongkorn Memorial Hospital between January 1995-September 2001. There were three hundred ninety nine cases of invasive breast cancer that available for estrogen (ER) and/or progesterone (PR) receptor status. The mean and median age in our study were 49.6 year and 49.0 year respectively. About 60.9 per cent of the patients were pre and peri-menopause and 37.8 per cent were post-menopause. Most of the histological cell type were invasive ductal carcinoma which comprised of 92.7 per cent. Histologic grading were nearly equal for moderately and poorly differentiated grade: 43.66 per cent and 40.66 per cent. The results of our study showed 53.4 per cent of 399 patients had ER positive and 42.1 per cent of 380 patients had PR positive. The proportion of ER+PR+, ER+PR-, ER-PR+, and ER-PR- were 36.31 per cent, 15.53 per cent, 5.79 per cent and 42.37 per cent respectively. Older age and post-menopause women had higher ER+. While patients with increase tumor size, poorly differentiated grading, increase positivity of axillary lymph nodes and higher stage have more chance of ER negative and PR negative.