Hemen K. Parikh

Efficacy of hydrolytic enzymes in preventing radiation therapy-induced side effects in patients with head and neck cancers.

Purpose: Based on in vitro and on clinical evidence of protection against acute side effects of radiation, a prospective randomized, open study was performed to determine the efficacy of an oral proteolytic enzyme preparation in patients with head and neck cancer receiving conventional fractionated radiation therapy. Methods: Patients with stage T3/T4 head and neck cancer were eligible. One hundred patients from two centres were entered into the study. 60Co gamma-radiation was delivered at a standard daily radiation dose of 2 Gy in 25–35 fractions over a period of 6–7 weeks. Two lateral parallel opposing fields were used with a portal area of 10 × 15 cm. Patients assigned to the test group arm additionally received enzyme tablets orally t.i.d. starting 3 days prior to radiation therapy, and continuing up to 5 days after completion of the course of radiation therapy. Patients in the control arm were not given any drug or placebo. Acute radiation side effects were described as mucositis, skin reaction, dysphagia, and were graded at each visit during and after radiation therapy, following RTOG/EORTC criteria. Results: The severity (maximum extent) of acute radiation therapy side effects was significantly less in enzyme-treated patients than in control patients: mucositis (mean: 1.3 vs 2.2, P < 0.001), skin reaction (1.2 vs 2.4, P < 0.001) and dysphagia (1.4 vs 2.2, P < 0.001). The duration of these side effects as well as the sum scores of side effects were also less in the study arm. Conclusions: Combination of enzyme therapy with conventional fractionated radiation therapy was feasible and well-tolerated. There was significant protection against acute side effects of radiation therapy in the study arm. Not only was the severity of acute side effects less but the duration was shorter and the time to onset was also delayed. Prospective randomized double-blind studies would verify this role of an oral enzyme therapy as standard co-medication with radiation therapy to the head and neck region.

Histologic trends in thyroid cancer 1969-1993: a clinico-pathologic analysis of the relative proportion of anaplastic carcinoma of the thyroid.

It was observed that new presentations of anaplastic carcinoma of the thyroid had become infrequent in the last two decades.

Prognostic factors in follicular carcinoma of the thyroid: a study of 198 cases.

Prognostic parameters for papillary carcinoma of the thyroid have been defined by several groups. However, no such study has been reported for follicular carcinoma.

Perioperative chemotherapy in patients with oral cancer

In the final report of a prospective, randomized controlled clinical trial, we report the results of using adjuvant perioperative chemotherapy in patients with oral cancer. Our study is based on the hypothesis of Goldie and Coldman. A total of 135 patients with alveolobuccal carcinoma, classified as clinically stage III and IV, were entered on the protocol. After a curative resection, they were randomized. The patients in the test arm of the study received methotrexate 50 mg/m2 on the 3rd, 10th, and 17th postoperative days. The patients in the control arm underwent observation. This analysis at 24 months showed a disease-free survival rate of 61% in the test arm versus 37% in the control arm, which is statistically highly significant (P < 0.01). Analysis of the recurrence pattern showed that recurrence at the primary site was dramatically reduced during the first 6 postoperative months (P = 0.002). Our study provided further clinical evidence in support of the concepts of Goldie and Coldman that the timing of chemotherapeutic drugs is critical for a successful end result.

Prognosticators of survival in differentiated thyroid carcinoma.

Differentiated carcinoma of the thyroid has good prognosis, even in patients presenting in the late stage and with distant metastasis. In India, the incidence of papillary carcinoma and follicular carcinoma are in the ratio of 60∶40. A retrospective study was carried out to determine the impact of patient and tumor factors on survival, and to develop a simple rish group staging system to predict survival in patients with differentiated thyroid carcinomas. Four hundred and seventeen (417) patients undergoing primary treatment at our hospital between 197–1985, were entered to the study. There were 198 follicular carcinomas and 219 papillary carcinomas. Impact of patient and tumor variables were studied by drawing Kaplan Meier curves and comparing them by the Chi Sq Test. Age<=40 years (p=0.00001), tumor size <5cms (p=0.01), extrrathyroidal spread (p=0.001) and distant metastasis (p=0.00001) had significant impact on survival. These finding were true for a subset analysis follicular and papillary carcinomas separately. A Cox Regression Analysis was also performed and this showed the above factors to impact significantly on survival. Basing on the regression analysis we devised a simple risk group system and classified the patients as high and low risk. Low risk group patients had a significant survival advantage. Our findings show that the incidence of follicular carcinoma is significantly high in india (48%) and that 65% of our patients are in the high risk group. Incidence of contralateral lobe disease on completion thyroidectomy is as high as 53%. Hence, a more aggressive treatment policy is warranted and total thyroidectomy is the appropriate treatment of choice in our patients.

Pharyngoesophageal segment manometry : Its role in determining post-laryngectomy speech

Pharyngoesphageal (P. E) segment manometry was performed in 15 patients to determine the significance of the tone of the neoglottis in post-laryngectomy speech. The time interval following laryngectomy ranged from 3 months to 19 years. Peak pressures and graphic records during esophageal and tracheoesophageal speech were obtained, using a Swan-Ganz catheter, arterial pressure transducer and monitor with recorder. Peak pressures below 22mm Hg. and above 30mm Hg. were associated with fluent (7 patients) and nonfluent (8 patients) speech respectively. All 5 patients with primary pharyngeal myotomy demonstrated low pressures with fluent speech. P. E. manometry accurately reflected the type of speech developed and identified abnormal tone of the neoglottis as the cause of speech failure. Pharyngeal myotomy should be performed in those who demonstrate high P. E. pressures with poor speech development after laryngectomy.

Surgery in early cancer of the oral tongue (Tl-2). Wide excision versus hemiglossectomy

Cancer of the oral tongue is a common disease. Thirty five (35%) percent of patients seen at our hospital are in Stages I&II. The choice of surgical treatment is a wide excision of the lesion (WE) or a hemiglossectomy (HG). This study was carried out to compare the local recu-rrences and survival in patients undergoing either a WE or HG for early cancer of the tongue. One hundred and twenty six (126) patients were evaluated, 40 underwent a WE and 86 HG. The local recurrence was higher in the WE group, 25% compared with 9% in the HG group; which is statistically significant (p=0.02). This was also seen in the Tl subgroup (p=0.003). Survival were better in the HG group (p=0.005), which was also seen for the Tl subgroup (p=0.004). Our study demonstrates that there is a lower incidence of local recurrences following a hemiglossectomy for Tl-2 tumours of the oral tongue with improved survivals. Our recommendation is that hemi-glossectomy should be the optimal surgery performed for early cancer of the oral tongue.