Quality of life in elderly breast cancer patients with localized disease receiving endocrine treatment: a prospective study.

PURPOSE: In this paper we study the quality of life (QoL) of elderly breast cancer patients receiving endocrine treatment (ET). More QoL data on elderly patients treated with ET are needed. Our aims are to study QoL in early-stage breast cancer patients throughout the treatment period and compare the QoL of ET groups. METHODS: 148 patients > 65 years who began ET with either tamoxifen or aromatase inhibitor (AI) completed the EORTC QLQ-C30 and QLQ-BR23 and the Interview for Deterioration in Daily Living Activities in Dementia (IDDD) questionnaires three times over 3 years of ET. Linear mixed-effect models were used to evaluate longitudinal QoL changes. ET group comparisons were conducted after 3 years of treatment via ANCOVA adjusted by basal QoL. RESULTS: QoL scores were high (> 80/100 points) in most QoL areas, with moderate limitations (> 30) in sexual functioning and enjoyment and in future perspective. After 3 years of ET, four QoL areas improved (< 6 points) compared to baseline and 3-month assessments. Hot flushes worsened (8 points) at the 3-month assessment but by 3 years had recovered. AI patients showed more hot flushes, pain and diarrhea and less sexual enjoyment than tamoxifen patients after 3 years of ET (differences 3-12 points). CONCLUSIONS: Results indicate that elderly early-stage breast cancer patients adapted well to their disease and ET treatment over the 3 years. Few QoL differences were observed between ET groups.

Correction to: Efficacy of fulvestrant in the treatment of postmenopausal women with endocrine-resistant advanced breast cancer in routine clinical practice.

A sentence under 'Results' heading in the Abstract section was published incorrectly. The correct sentence should read as follows.

Efficacy of fulvestrant in the treatment of postmenopausal women with endocrine-resistant advanced breast cancer in routine clinical practice.

INTRODUCTION: This study aimed to describe the efficacy of fulvestrant 500 mg in postmenopausal women with estrogen receptor (ER)-positive advanced/metastatic breast cancer who had disease progression after receiving anti-estrogen therapy in clinical practice, getting real-world data. MATERIALS AND METHODS: Multicenter, retrospective, observational study conducted in Spain. Postmenopausal women with locally advanced/metastatic ER-positive breast cancer who received treatment with fulvestrant 500 mg after progression with a previous anti-estrogen therapy were eligible. The primary endpoint was progression-free survival (PFS); secondary endpoints were overall survival (OS), clinical benefit rate (CBR), duration of clinical benefit (DoCB), and safety profile. RESULTS: A total of 263 women were evaluated (median age, 65.8 years). At a median follow-up of 21.5 months, median PFS and OS were 10.6 and 43.2 months, respectively. PFS according to 1st, 2nd, 3rd, and ≥ 4th lines were 11.5, 10.6, 9.9, and 8.5 months, respectively (p = 0.0245). PFS in patients with visceral involvement was 10 months vs 10.6 months in patients without visceral involvement (p = 0.6604), 9.6 months in patients with high Ki67 vs 10 months in patients with low Ki67 (p = 0.7224), and 10.2 months in HER2+ patients vs 10.3 months in HER2- patients (p = 0.6809). The CBR was 56.5% and the DoCB was 18.4 months. The most frequently adverse events were injection site pain (10.3%) and musculoskeletal disorders (7.6%). CONCLUSIONS: Fulvestrant 500 mg administered in clinical practice was shown to be effective (PFS, 10.6 months; CBR, 56.5%) and well tolerated, in accordance with previous trials.

Erratum:Quality of life in long-term premenopausal early-stage breast cancer survivors from Spain. Effects of surgery and time since surgery.

In this article published in Volume 21, issue 5, the authors' names were incorrectly stated in the Pubmed abstract as: "Ignacio Arraras J(1), Juan Illarramendi J, de la Cruz S, Asin G, Manterola A, Ibanez B, Salgado E, Cambra K, Zarandona U, Angel Dominguez M, Vera R.". The correct authors' names are: "Arraras JI(1), Illarramendi JJ, de la Cruz S, Asin G, Manterola A, Ibanez B, Salgado E, Cambra K, Zarandona U, Dominguez MA, Vera R.". This error appeared only in the PubMed database and not in the print form of the Journal.

[Health-related quality of life in the oncology departments of the hospital of Navarra. The EORTC Quality of Life Group]. / Calidad de vida relacionada con la salud en los servicios de Oncología del Hospital de Navarra. Grupo de Calidad de Vida de la.

Quality of life assessment is one of the key elements of the care that is offered to cancer patients. The aim of this work is to present the research line on quality of life that has been carried out since 1992 in the Oncology Departments of the Hospital de Navarra. These departments actively collaborate with the European Organisation of Research and Treatment of Cancer - EORTC - Quality of Life Group in creating questionnaires and also in other projects of this group. Our institution has coordinated the development process of the EORTC information module. Different EORTC questionnaires have been validated for use in our country. Quality of life studies have been carried out in the main tumour sites and in other areas, such as patients' satisfaction with care. This research line has a direct benefit on the attention that patients receive.

[Acral keratoses and inverted follicular keratosis presenting Cowden disease]. / Queratosis acras y queratosis folicular invertida como manifestación de la enfermedad de Cowden.

Cowden disease is a rare genetic disorder characterized by the presence of multiple hamartomas in the skin, thyroid, breast, nervous system and gastrointestinal tract. Mucocutaneous lesions are the most constant and characteristic finding. Breast and thyroid neoplasms (benign and malignant) develop in up to two thirds of patients. Inverted follicular keratosis as the presenting feature of Cowden disease is rare as the disease is usually suspected by the appearance of multiple facial trichilemmomas, oral mucosal papillomatosis and acral keratoses.

[Treatment of emesis induced by chemotherapy]. / Tratamiento de la emesis inducida por quimioterapia.

Respiratory emergencies in a patient with cancer can have their origin in pathologies of the airway, of the pulmonary parenchyma or the large vessels. The cause can be the tumour itself or concomitant complications. Obstruction of the airway should be initially evaluated with endoscopic procedures. Surgery is rarely possible in serious situations. The endobronchial placement of stents or radioactive isotopes (brachytherapy), tumoural ablation by laser or photodynamic therapy can quickly alleviate the symptoms and re-establish the air flow. Treatment of haemoptysis depends on the cause that is provoking it and on its quantity. Bronchoscopy continues to be the front line procedure in the majority of cases; it provides diagnostic information and can interrupt bleeding through washes with ice-cold serum, endobronchial plugging or topical injections of adrenaline or thrombin. External radiotherapy continues to be an extraordinarily useful procedure in treating haemoptysis caused by tumours and in carefully selected situations of endobronchial therapy with laser or brachytherapy, and bronchial arterial embolisation can provide a great palliative effect. Respiratory emergencies due to pulmonary parenchyma disease in the oncology patient can have a tumoural, iatrogenic or infectious cause. Early recognition of each of these will determine the administration of a specific treatment and the possibilities of success.

Polymorphisms of the repeated sequences in the enhancer region of the thymidylate synthase gene promoter may predict downstaging after preoperative chemoradiation in rectal cancer.

PURPOSE: Thymidylate synthase (TS) is an important target enzyme for the fluoropyrimidines. TS gene promoter possesses regulatory tandemly repeated (TR) sequences that are polymorphic in humans, depending on ethnic factors. These polymorphisms have been reported to influence TS expression. TS expression levels affect tumor downstaging after preoperative fluoruracil (5-FU)-based chemoradiation. Tumor downstaging correlates with improved local control and disease-free survival. The aim of this study is to correlate TR polymorphisms with downstaging and disease-free survival. PATIENTS AND METHODS: Sixty-five patients with rectal cancer underwent tumor resection after preoperative 5-FU-based chemoradiation. Tumor downstaging was evaluated by comparing the pretreatment T stage with the pathologic stage observed in the surgical specimen. TS polymorphism genotype was determined by polymerase chain reaction amplification of the corresponding TS promoter region, and products of amplification were electrophoresed, obtaining products of 220 bp (2/2), 248 bp (3/3), or both (2/3). The TS polymorphism genotype results were subsequently compared with the downstaging observed and with disease-free survival. RESULTS: Patients who were homozygous for triple TR (3/3) had a lower probability of downstaging than patients who were homozygous with double TR or heterozygous patients (2/2 and 2/3): 22% versus 60% (P =.036; logistic regression). Furthermore, a trend toward improved 3-year disease-free survival was detected in the 2/2 and 2/3 groups, compared with that in the 3/3 group (81% v 41%; P =.17). CONCLUSION: This preliminary study suggests that TS repetitive-sequence polymorphisms are predictive for tumor downstaging. TR sequences in TS promoter may be useful as a novel means of predicting response to preoperative 5-FU-based chemoradiation.

Hyperfractionated radiotherapy concomitant with cisplatin and granulocyte colony-stimulating factor (filgrastim) for laryngeal carcinoma.

An open-label, non-randomized study evaluated the feasibility and efficacy of filgrastim (recombinant methionyl human granulocyte colony-stimulating factor, r-metHuG-CSF) to prevent mucositis induced by accelerated hyperfractionated radiotherapy (1.6 Gy b.i.d., total dose 67.2 Gy in six weeks with a two-week split) and concomitant chemotherapy (cisplatin, 20 mg/m2/day, days 1-5 by continuous intravenous infusion) in patients with laryngeal carcinoma. Filgrastim 300 microg/day was administered on days 1, 3, and 5 in weeks 2-6 of radiotherapy, after the second fraction. Twenty patients (three stage II, six stage III, and eleven stage IV, according to AJCC) were enrolled in the trial. Oral mucosal toxicity was grade 2 in nine patients (45%), grade 3 in eight (40%), and grade 4 in three (15%). Severe hematological toxicity (WHO criteria) was uncommon. Nineteen patients (95%) completed the treatment in the planned time. Overall survival was 55% at three years. The administration of filgrastim with this regimen was feasible, and it appeared to reduce the severity and duration of mucositis induced by the combined treatment.

Chemoradiotherapy for muscle invading bladder carcinoma. Final report of a single institutional organ-sparing program.

PURPOSE: Chemoradiotherapy is becoming an alternative to radical cystectomy among patients with muscle invading bladder cancer. We began a prospective study in 1988 to determine the possibilities of conservative treatment and aiming to improve the results obtained by cystectomy alone in invasive bladder cancer. A combination of methotrexate, vinblastine, adriamycin, and cisplatin (M-VAC), followed by radiotherapy and concomitant cisplatin was used. METHODS: Fifty patients with good performance status and with stages T2 to T4 operable untreated invasive bladder cancer were entered in the study. Treatment protocol was as follows: (i) cytoreductive transurethral resection; (ii) two cycles of M-VAC chemotherapy; (iii) radiotherapy, 45 Gy on pelvic volume and, at the same time, 20 mg/m(2) cisplatin on days 1 to 5. Cystoscopic evaluation: if there was a complete response, radiotherapy was completed up to 65 Gy; if there was not a complete response, a cystectomy was performed. Median follow-up of the series was 73 months (18-180 m). RESULTS: Tumor response was as follows: 34 complete responses (68%), 9 partial responses (18%), and 7 nonresponses (14%) were observed. The 5-year overall survival and local control were 48% and 47%, respectively. For the complete responder patient, 5-year survival and local control were 65% and 70%, respectively. Severe toxicity was uncommon. The most frequent were leucopenia and cystitis. No treatment-related deaths occurred with either treatment protocol. CONCLUSIONS: Conservative combination treatment may be an acceptable alternative to immediate cystectomy in selected patients with bladder cancer, although a randomized clinical trial would be required to produce definitive results.

Radical chemoradiotherapy for elderly patients with bladder carcinoma invading muscle.

BACKGROUND: Chemoradiotherapy is becoming an alternative to radical cystectomy among patients with bladder carcinoma invading muscle. In 1988, the authors began a protocol with methotrexate, vinblastine, doxorubicin, and cisplatin (M-VAC regimen) and radiotherapy for these patients. Traditionally, age has been considered a determinant factor thereby excluding the older patients from the oncologic protocols that are considered to be more aggressive. The authors analyzed 20 patients (age > 70 years) who were treated during this period with the same protocol as the authors' other patients. METHODS: The study included 20 patients (age range, 70-78 years; median age, 74 years) including 4 patients with T2 disease, 9 with T3 disease, and 7 with T4 disease. All patients had a Karnofsky performance status of > 60. Treatment protocol included cytoreductive transurethral resection, 2 cycles of M-VAC chemotherapy, and radiotherapy (45 grays [Gy] on pelvic volume) with concurrent cisplatin (20 mg/m2 on Days 1-5. Response was determined by cystoscopic evaluation. If there was a complete response, radiotherapy continued until a total dose of 65 Gy; if there was not a complete response, cystectomy was performed. RESULTS: Tumor response after a dose of 45 Gy included 11 complete responses (55%), 5 partial responses (25%), and 4 nonresponses (20%). Overall survival was 75%, 34%, and 27% in the 2nd, 3rd, and 5th years of follow-up, respectively. Cause specific survival was 79%, 54%, and 38%, respectively. Survival for patients with complete response was 100%, 60%, and 48%, respectively. Severe toxicity was uncommon, with the most frequent toxicities being leukopenia and cystitis. No treatment-related death occurred with either treatment protocol. CONCLUSIONS: The age of the individual must not become a strict exclusion criterion for the radical treatment of old patients with invasive bladder carcinoma.

Split hyperfractionated accelerated radiation therapy and concomitant cisplatin for locally advanced head and neck carcinomas: a preliminary report.

PURPOSE: The feasibility and activity of an intensive chemoradiotherapeutic scheme for patients with locally advanced squamous cell head and neck cancers were tested in a single institution Phase II pilot study. METHODS AND MATERIALS: Between January 1990 and February 1992, 40 patients were entered into this trial. The treatment protocol consisted of split hyperfractionated accelerated radiation therapy (SHART), 1.6 Gy per fraction given twice per day to a total dose of 64-67.2 Gy for a total of 6 weeks with a 2-week gap, and cisplatin (20 mg/sqm/Days 1 to 5, in continuous perfusion) concomitantly. RESULTS: All of the 40 patients are evaluable for response and survival. Toxicity was significant, but tolerable. A complete tumor response to this treatment was achieved by 37 patients (92.5%). With a minimal follow-up of 22 months (median 30 months) there have been 16 local relapses and 19 patients have died, 2 without tumor. The projected 2- and 3-year overall survival rates are 64% (confidence interval (CI) 95%, 49-79%) and 47%, respectively. The 2-year local control probability has been 56% (CI 95%, 39-73%). CONCLUSION: This treatment obtains a high rate of complete responses with increased acute toxicity but tolerable late effects. Preliminary results are encouraging for laryngeal neoplasms. A longer follow-up is needed to evaluate the impact of this treatment on patient survival.

Mitomycin, cisplatin, and vindesine followed by radiotherapy combined with cisplatin in stage III nonsmall cell lung cancer: long-term results.

PURPOSE: To assess the tolerance, response rate, pattern of failure, and long-term survival of patients with unresectable nonsmall cell lung cancer treated with one cycle of induction chemotherapy followed by concurrent cisplatin and radiotherapy. METHODS AND MATERIALS: From 1986 to 1988, 45 patients with histologically proven nonsmall cell lung cancer clinical Stage III (29 IIIA and 16 IIIB) were included in this study. Patients received one cycle of Mitomycin C 10 mg/m2 day 1, Cisplatin 120 mg/m2 day 1, and Vindesine 3 mg/m2 days 1, 8, 15, and 22, by i.v. bolus injection. Radiotherapy was started within 4-6 weeks after completion of chemotherapy, with a total tumor dose of 60 Gy, at 2 Gy/day. Cisplatin, 20 mg/m2/day by i.v. continuous infusion was administered for days 1-5 of radiation treatment. RESULTS: The main toxic acute effects were nausea-vomiting grade 1-3 in 38 patients (85%). Ten patients (22%) developed esophagitis grade 3. Leukopenia grade 1-2 was observed in 18 patients (40%), grade 3 in 12 (27%), and grade 4 in 4 (9%). Three patients (6.6%) died by granulocytopenia and sepsis. A bronchoscopic proven complete response was achieved in 9 patients (21.5%) and partial response in 28 patients (67%). With a minimum follow-up of 65 months, overall median survival was 13 months, 2-year survival was 21%, and 5-year survival was 7%, with no statistical difference between Stage IIIA and IIIB. Median survival of patients with complete response was 23.2 months, and 5-year survival was 33%. CONCLUSION: This treatment scheme produced a severe toxicity and in spite of a high response rate, long-term survival is poor, similar to previous studies with radiotherapy alone.

Neoadjuvant chemotherapy and radiotherapy in locally advanced esophagus carcinoma: long-term results.

PURPOSE: A prospective study with neoadjuvant chemotherapy and radiotherapy in patients with locally advanced esophagus carcinoma for evaluating: toxicity, response rate, pattern of recurrence, and survival after a long follow-up. METHODS AND MATERIALS: Between 1983-1988, 40 patients with locally advanced squamous cell carcinoma of the thoracic esophagus were entered into a prospective trial of neoadjuvant chemotherapy and radiotherapy. Eight patients (20%) were Stage II and 32 patients (80%) were Stage III, according to American Joint Committee staging criteria. Neoadjuvant chemotherapy consisted of two cycles with cisplatin (120 mg/m2 day 1), vindesine (3 mg/m2 days 1, 8, 15, and 22) and bleomycin (10 mg/m2 days 3 to 6). Second cycle was initiated on day 29. Radiation therapy was administered 2-4 weeks after completion of chemotherapy, with a total dose on tumor of 60 Gy. RESULTS: Two patients died from treatment-related toxicity. Complete response was observed in 20 patients (53%) and symptomatic improvement in 31 patients (82%). The median survival was 11 months, with an actuarial survival at 1 year of 45%, 3 year 20%, and 5 years 15%. Significantly (p < 0.05) longer survival was observed in patients with Stage II (median survival 18 months) vs. Stage III (median survival 10 months). The pattern of failure was predominantly local/regional (62%). CONCLUSION: This treatment scheme is an effective and tolerable regimen but long-term survival was poor.

Low dose epirubicin for hypercalcemia associated with renal pelvis carcinoma.

We present a case of hypercalcemia associated with a renal pelvis squamous neoplasm. Severe hyperleukocytosis was also present, resembling a leukaemoid reaction. After failure of standard therapy, we performed a trial of low dose epirubicin in this patient, obtaining a short-term clinical remission. Although a palliative non-toxic effect seems to be achievable with this approach, further studies are needed to ascertain the role of chemotherapy in the long-term control of this condition.