Clinical and economic implications of the use of nanoparticle paclitaxel (Nanoxel) in India.

Paclitaxel (Taxol), one of the most commonly used chemotherapeutic agents, is poorly soluble in water and requires cremophor, which often causes infusion reactions, as a solvent. Nanoxel, a nanoparticle formulation of the taxane, has been approved by the Indian regulatory authority. In the present article, we aim to describe the experience with the use of Nanoxel in India and its clinical and economic implications. We present three retrospective series in a common practice environment and an economic model. The first series shows no reactions in 596 Nanoxel infusions; the second series shows comparable adverse events other than infusion reactions between 83 patients who received Nanoxel and 32 treated with conventional paclitaxel. The third reveals comparable clinical outcomes for 51 patients treated with Nanoxel or conventional paclitaxel for gastroesophageal tumors. Finally, we describe an economic model which estimates savings of 21 580 Indian rupees per cycle with Nanoxel vis-à-vis conventional paclitaxel in the treatment of solid tumors in India. In conclusion, in an era in which the greatest challenge we face as medical oncologists is how to conciliate hard-won and incremental--but small--improvements in survival with exponentially rising drugs costs, it is refreshing to see a potential new formulation of a commonly used drug that may actually generate cost-savings while improving clinical outcomes and patient well-being. Further studies are clearly warranted to determine the optimal dose and schedule for Nanoxel as well as its comparative effectiveness to cremophor-based paclitaxel.

Improved management of abdominal undescended testicular tumors with bulky confluent retroperitoneal nodal metastases.

PURPOSE: Germ cell tumors of the abdominal undescended testis associated with confluent bulky retroperitoneal metastases are challenging problems. We report the results of neoadjuvant cisplatin based chemotherapy after diagnosis of germ cell tumors by fine needle aspiration cytology of the abdominal testicular mass. After chemotherapy all patients underwent abdominal orchiectomy with retroperitoneal lymph node dissection for residual nonseminomatous germ cell tumors or radiotherapy for pure seminomas. MATERIALS AND METHODS: Between 1980 and 1991, 57 of 425 patients (13.4%) with germ cell tumors of the testicle had malignancy in an undescended testis, while 39 (68.4%) had tumor in an abdominal testis with confluent bulky metastasis. Metastatic evaluation included tumor marker studies, chest x-ray and computerized tomography of the abdomen. Among the tumors 29 (74.4%) were large volume seminomas (stages IIc, III and IV) and 10 (25.6%) were large volume nonseminomas. All 39 patients received 3 cycles of induction chemotherapy, and orchiectomy was deferred until its completion (14 received vinblastine, actinomycin D and bleomycin-6, and 25 received bleomycin, etoposide and cisplatin). After evaluation of response, the testis was excised. Overall followup was 2 to 12 years (median 4.6). RESULTS: Of 29 seminomas 14 (48.3%) showed a complete and 11 (37.9%) showed a partial response. The latter tumors were treated subsequently with radiotherapy. Four patients with progressive disease died, for an actuarial survival rate of 86%. Of the 10 patients with nonseminomatous germ cell tumor 2 (20%) had a complete response and 4 had a partial response. All patients with a partial response underwent retroperitoneal lymph node dissection. Overall, 4 patients with progression and 2 with a partial response died, for an actuarial survival rate of 39%. Of 39 post-chemotherapy orchiectomy specimens 24 (61.5%) showed viable tumor cells. Furthermore, 16 of 39 patients (41%) had additional ilioinguinal metastases requiring adjuvant radiotherapy or surgery. CONCLUSIONS: Surgical removal of the primary tumor in an undescended testis with bulky metastasis is difficult. We believe that initial chemotherapy followed by 1-stage surgical removal of the primary and residual metastasis is a favorable option to improve compliance and decrease the incidence of loss to followup. Atypically altered ilioinguinal metastases may necessitate a change in radiotherapy ports and/or retroperitoneal lymph node dissection boundaries. The significantly poorer survival with nonseminomatous germ cell tumor could be due to the fact that 50% of the lesions were stage IV at presentation. However, multivariate analysis showed only tumor histology to be the significant parameter and not initial stage at presentation.