Adjuvant regimens with trastuzumab administered for small HER2-positive breast cancer in routine clinical practice

Purpose. Trastuzumab has proven to improve the prognosis of HER2-positive breast cancer, but the information available about its administration for small tumors is still limited. Therefore, we assessed the use of adjuvant regimens with trastuzumab for the treatment of small HER2-positive breast cancer in routine clinical practice. Methods. This observational study was conducted in patients with HER2-positive breast adenocarcinoma ≤1.5 cm who received trastuzumab-based adjuvant treatment in clinical practice. Clinical/histopathological data were retrieved from patients’ medical charts. Results. A total of 101 evaluable patients were enrolled (median age [range], 56.7 [49.0–64.8] years; ECOG 0, 98.0 %; ductal carcinoma, 88.1 %; lymph nodes N0, 79.2 %). Only five (5.0 %) patients received neoadjuvant treatment, while all patients underwent tumor surgery. Adjuvant trastuzumab was administered at a mean (±SD) dose of 5.9 ± 1.5 mg/kg/cycle, and mostly in a three-weekly schedule (89 [89.0 %] patients). The most frequent adjuvant therapy used with trastuzumab was chemotherapy (87 [86.1 %] patients), followed by radiotherapy (63 [62.4 %] patients) and hormone therapy (52 [51.5 %] patients). Chemotherapy regimens mainly included doxorubicin, cyclophosphamide and paclitaxel/docetaxel (n = 30), docetaxel and cyclophosphamide (n = 15), docetaxel and carboplatin (n = 13). Hormone therapy mainly included letrozole (n = 17) and tamoxifen (n = 17). Nine (8.9 %) patients reported trastuzumab-related adverse events; only one allergic reaction reached grade 3 toxicity. Conclusion. This study shows that trastuzumab-based adjuvant treatment of small HER2-positive breast cancer is mostly based on chemotherapy—mainly paclitaxel/docetaxel. Adjuvant administration of trastuzumab for small HER2-positive breast cancer seems to be similar to that used for larger tumors (AU)

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Adjuvant regimens with trastuzumab administered for small HER2-positive breast cancer in routine clinical practice.

PURPOSE: Trastuzumab has proven to improve the prognosis of HER2-positive breast cancer, but the information available about its administration for small tumors is still limited. Therefore, we assessed the use of adjuvant regimens with trastuzumab for the treatment of small HER2-positive breast cancer in routine clinical practice. METHODS: This observational study was conducted in patients with HER2-positive breast adenocarcinoma ≤1.5 cm who received trastuzumab-based adjuvant treatment in clinical practice. Clinical/histopathological data were retrieved from patients' medical charts. RESULTS: A total of 101 evaluable patients were enrolled (median age [range], 56.7 [49.0-64.8] years; ECOG 0, 98.0 %; ductal carcinoma, 88.1 %; lymph nodes N0, 79.2 %). Only five (5.0 %) patients received neoadjuvant treatment, while all patients underwent tumor surgery. Adjuvant trastuzumab was administered at a mean (±SD) dose of 5.9 ± 1.5 mg/kg/cycle, and mostly in a three-weekly schedule (89 [89.0 %] patients). The most frequent adjuvant therapy used with trastuzumab was chemotherapy (87 [86.1 %] patients), followed by radiotherapy (63 [62.4 %] patients) and hormone therapy (52 [51.5 %] patients). Chemotherapy regimens mainly included doxorubicin, cyclophosphamide and paclitaxel/docetaxel (n = 30), docetaxel and cyclophosphamide (n = 15), docetaxel and carboplatin (n = 13). Hormone therapy mainly included letrozole (n = 17) and tamoxifen (n = 17). Nine (8.9 %) patients reported trastuzumab-related adverse events; only one allergic reaction reached grade 3 toxicity. CONCLUSION: This study shows that trastuzumab-based adjuvant treatment of small HER2-positive breast cancer is mostly based on chemotherapy-mainly paclitaxel/docetaxel. Adjuvant administration of trastuzumab for small HER2-positive breast cancer seems to be similar to that used for larger tumors.

Effectiveness of daily versus non-daily granulocyte colony-stimulating factors in patients with solid tumours undergoing chemotherapy: a multivariate analysis of data from current practice.

We conducted a multicentre, retrospective, observational study including patients with solid tumours (excluding breast cancer) that received granulocyte colony-stimulating factors (G-CSF) and chemotherapy. We investigated the effectiveness of daily vs. non-daily G-CSFs (pegfilgrastim) adjusting by potential confounders. The study included 391 patients (211 daily G-CSF; 180 pegfilgrastim), from whom 47.3% received primary prophylaxis (PP) (57.8% pegfilgrastim), 26.3% secondary prophylaxis (SP: initiation after cycle 1 and no reactive treatment in any cycle) (51.5% pegfilgrastim) and 26.3% reactive treatment (19.4% pegfilgrastim). Only 42.2% of patients with daily G-CSF and 46.2% with pegfilgrastim initiated prophylaxis within 72 h after chemotherapy, and only 10.5% of patients with daily G-CSF received it for ≥ 7 days. In the multivariate models, daily G-CSF was associated with higher risk of grade 3-4 neutropenia (G3-4N) vs. pegfilgrastim [odds ratio (OR): 1.73, 95% confidence interval (CI): 1.004-2.97]. Relative to SP, PP protected against G3-4N (OR for SP vs. PP: 6.0, 95%CI: 3.2-11.4) and febrile neutropenia (OR: 3.1, 95%CI: 1.1-8.8), and was associated to less chemotherapy dose delays and reductions (OR for relative dose intensity <85% for SP vs. PP: 3.1, 95%CI: 1.7-5.4) and higher response rate (OR: 2.1, 95%CI: 1.2-3.7). Data suggest that pegfilgrastim, compared with a daily G-CSF, and PP, compared with SP, could be more effective in preventing neutropenia and its related events in the clinical practice.

Generalised erythematous skin eruptions induced by sorafenib: cutaneous toxicity and treatment outcome

A woman diagnosed of a renal cell carcinoma in 1989 had a metastatic kidney cancer localised in subcutaneous nodules, gut and lung in 2007. Sorafenib treatment was initiated a 400 mg orally twice a day. The patient developed generalised erythematous skin eruptions and two weeks later a widespread erythematous maculopapular eruption located exclusively on the legs and arms, along with an objective response. The most likely cause of the generalised erythematous skin eruptions was considered to be sorafenib because of the close temporal relationship between exposure to the drug and onset of symptoms. Furthermore, a relationship between sorafenib skin toxicity and treatment efficacy was observed. This therapeutic efficacy of EGFR inhibitors and cutaneous side effects should be better assessed in large cohorts or trials to determine whether the skin toxicity of patients can be linked to an objective antitumour response (AU)

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Successful desensitization protocol for hypersensitivity reactions caused by oxaliplatin.

OBJECTIVE: To report the successful desensitization of a patient with a hypersensitivity reaction to oxaliplatin. CASE SUMMARY: A 57-year-old woman with metastatic colon cancer was receiving oxaliplatin, fluorouracil and leucovorin every 2 weeks and showed a partial response to therapy. During the fourth cycle, an anaphylactic reaction with palpitations and rash occurred. The patient was hypotensive with mild pulmonary wheezing. Since oxaliplatin was the probable cause of the hypersensitivity reaction, therapy with this drug was discontinued. Therapy in the patient was continued using cetuximab and irinotecan but this resulted in progression of the cancer. In view of the initial satisfactory response to the oxaliplatin-based regimen, it was decided to attempt desensitization to oxaliplatin using a protocol adapted from carboplatin regimens. The desensitization procedure was successful and the patient subsequently tolerated an additional three cycles using this regimen without further symptoms of hypersensitivity. DISCUSSION: In cases with moderate-to-severe reactions to oxaliplatin, reexposure is not usually considered. However, a need to use first-line therapy when there is recurrence of the cancer has encouraged the development of rapid desensitization procedures which allow patients to be treated with medications to which they have previously shown hypersensitivity reactions. A combination of premedication using intravenous dexamethasone and a desensitization regimen was designed which was used successfully to increase concentrations and flow rates of oxaliplatin. CONCLUSIONS: Hypersensitivity reactions to oxaliplatin are not rare and physicians need to be aware of these. When substitution of another antineoplastic drug is not feasible, oxaliplatin desensitization should be considered even when hypersensitivity reactions to oxaliplatin are severe.

Possible delayed onset of osteonecrosis of the jaw in association with zoledronic acid.

OBJECTIVE: To report a case of possible delayed-onset osteonecrosis of the jaw after treatment with zoledronic acid. CASE SUMMARY: A 53-year-old white man with no history of allergic drug reactions had been diagnosed as having bronchial epidermoid carcinoma. He received therapy with docetaxel and zoledronate. Because of metastatic progression of the disease, he started treatment with irinotecan and zoledronate. The patient received 18 monthly cycles of zoledronate. One year after the last cycle of bisphosphonate therapy, the patient had one tooth extracted. Three weeks later, he complained of continuous mandibular pain and swallowing difficulties. A diagnosis of osteonecrosis of the jaw was made. Surgical treatment was chosen, with debridement and a mucosal flap, complemented with antibiotic therapy. Other potential aetiologic risk factors for osteonecrosis were investigated and could not be identified. Accordingly, a diagnosis of possible delayed onset jaw osteonecrosis associated with zoledronate was made. DISCUSSION: Osteonecrosis of the jaws has recently emerged as a potential complication of bisphosphonate therapy in patients with metastatic cancer undergoing dental surgery. This is the first report of possible delayed-onset osteonecrosis of the jaw associated with zoledronate. Patients appear to remain at low risk of developing osteonecrosis even in the absence of zoledronate, especially after a dental extraction or oral surgery. Based on the Naranjo algorithm the adverse reaction was classed as possible.

Possible macular exanthema associated with linezolid therapy.

OBJECTIVE: To report a case of macular exanthema associated with linezolid therapy. CASE SUMMARY: A 54-year-old white man diagnosed as having laryngeal epidermoid carcinoma attended our emergency department because of fatigue, fever, neck pain and a fistulized fixed mass in the right side of the neck with purulent exudation. Treatment with amoxicillin/clavulanic acid 875 mg/125 mg p.o. every 8 hours as empirical therapy was started. Cultures of the exudates from the fistula confirmed the presence of methicillin-resistant Staphylococcus aureus (MRSA). Amoxicillin/clavulanic acid was discontinued and therapy was started with linezolid 600 mg p.o. every 12 hours but 5 days after commencing linezolid the patient came to our emergency room because of generalized erythematous macular eruptions. A diagnosis of severe and generalized macular exanthema induced by linezolid was made. Administration of linezolid was suspended and there was an improvement in the skin lesions and general state of health. The patient was discharged without further symptoms. DISCUSSION: In this case, there was a close temporal correlation between drug exposure and the onset of symptoms. When linezolid was discontinued, the skin lesions resolved quickly and the general condition of the patient improved. Furthermore, linezolid was the only drug added before the cutaneous lesions appeared. It is possible that the adverse reaction was associated with administration of amoxicillin/clavulanic acid. However, the patient had been treated with this antibiotic previously without appearance of any cutaneous reaction. An objective causality assessment revealed that an adverse effect was possible. CONCLUSION: Based on our observations, we conclude that linezolid was the most likely cause of the adverse reaction. Clinicians should be aware of this infrequent but severe reaction.

Osteonecrosis maxilar asociada a zoledronato / No disponible

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Metástasis infrecuentes de carcinoma epidermoide de laringe. A Propósito de dos casos / Infrequent metastases from larynx epidermoid carcinoma. Report of two cases

Propósito: El carcinoma epidermoide de laringe metastatiza con frecuencia en pulmón, esqueleto y esófago. Recientemente hemos tratado dos pacientes con carcinoma de laringe que recidivaron en sitios poco habituales, en piel de los dedos y en médula ósea. Material y métodos: Presentamos un paciente que además de la progresión local de su enfermedad tras cirugía, quimioterapia (QT) y radioterapia (RT), presentó afectación secundaria de la piel de los dedos de las manos. El segundo caso es el de un varón, que tras el diagnóstico y tratamiento de carcinoma de laringe presentó como único signo de recidiva, infiltración de médula ósea. Conclusiones: La afectación secundaria de la médula ósea y de la piel por un carcinoma epidermoide de laringe es rara. El interés de estos casos radica en lo poco común de estas localizaciones y en su mal pronóstico (AU)

[Treatment of advanced prostatic carcinoma with ketoconazole. Our experience in 10 cases]. / Tratamiento del carcinoma prostático avanzado con ketoconazol. Nuestra experiencia en diez casos.

We have treated 10 patients with histologically diagnosed prostate carcinoma, in states C and D, with orally administered dosage of 1200 mg./day of ketoconazol, with the following results: Four patients were excluded through displaying gastrointestinal intolerance in the first days of treatment. Three patients treated had the dosage reduced to half due to poor tolerance, but no improvement was noted. Another three patients tolerated the treatment for four months and displayed transitory remission of ostealgia, which permitted the withdrawal of analgesics. In these patients the treatment was suspended due to digestive intolerance and to the appearance of a clinical picture compatible with suprarrenal corex hypoadrenalism.

[Peripheral blood lymphocyte populations in 2 cases of Behçet syndrome]. / Estudio de las poblaciones linfocitarias en sangre periférica en dos casos de síndrome de Behçet.

The lymphocytes subsets in peripheral blood were studied in two patients with Behçet's syndrome. The finding about the decrease of T lymphocytes with the ratio elevated and specially the increase of B lymphocytes favors the hypothesis of predominance of the antibody formation over the cellular cytotoxicity.